Універсальний метод визначення амлодипіну в лікарських засобах промислового та екстемпорального виготовлення
A universal UV spectrophotometric method for determining amlodipine besylate in industrially manufactured and extemporaneously prepared medicinal products in the form of tablets, powders, and oral solutions has been developed and validated. The methodological concept is based on the use of a single...
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| Published in: | Журнал органічної та фармацевтичної хімії |
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| Date: | 2026 |
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| Pages: | 3-12 |
| ISSN: | 2518-1548 |
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| author | Bevz, Olena V. Kryvanych, Oleksandr V. Bevz, Nataliia Yu. Georgiyants, Victoriya A. |
| author_facet | Bevz, Olena V. Kryvanych, Oleksandr V. Bevz, Nataliia Yu. Georgiyants, Victoriya A. |
| author_institution_txt_mv | [
{
"author": "Olena V. Bevz",
"institution": "National University of Pharmacy of the Ministry of Health of Ukraine",
"orcid": ""
},
{
"author": "Oleksandr V. Kryvanych",
"institution": "State University “Uzhhorod National University”",
"orcid": ""
},
{
"author": "Nataliia Yu. Bevz",
"institution": "National University of Pharmacy of the Ministry of Health of Ukraine",
"orcid": ""
},
{
"author": "Victoriya A. Georgiyants",
"institution": "National University of Pharmacy of the Ministry of Health of Ukraine",
"orcid": ""
}
] |
| author_sort | Bevz, Olena V. |
| baseUrl_str | https://ophcj.nuph.edu.ua/oai |
| collection | OJS |
| container_end_page | 12 |
| container_issue | 1 |
| container_start_page | 3 |
| container_title | Журнал органічної та фармацевтичної хімії |
| container_volume | 24 |
| datestamp_date | 2026-08-24T19:33:19Z |
| description | A universal UV spectrophotometric method for determining amlodipine besylate in industrially manufactured and extemporaneously prepared medicinal products in the form of tablets, powders, and oral solutions has been developed and validated. The methodological concept is based on the use of a single analytical model applicable to various dosage forms and dissolution media without modifying the analytical conditions. Spectral studies confirmed the presence of two absorption maxima at (238 ± 2) nm and (365 ± 2) nm, which corresponded to different chromophoric systems of the molecule and could be used to identify the compound; the wavelength of 365 nm was selected as the analytical wavelength, providing improved selectivity for the quantitative determination of the active pharmaceutical ingredient. The method was validated in accordance with pharmacopoeial requirements and ICH guidelines. The procedure is characterized by precision, accuracy, specificity, and linearity in the range of 0.04–0.06 μg mL-1 (80–120% of the nominal concentration) (r > 0.9981) in all solvents proposed. The limits of detection (LOD) and quantification (LOQ) calculated were 0.59% and 0.92% for medicinal products in tablet and powder dosage forms, and 0.84% and 1.09% for the oral solution, respectively. The uncertainty of the method, including contributions from the sample preparation and the final analytical operation, was within acceptable limits for spectrophotometric assay procedures. The method proved to be applicable to industrial tablets, as well as extemporaneous powders and oral solutions, without interference from excipients in different dissolution media. Due to the minimal solvent consumption and the absence of requirements for chromatographic equipment, the approach proposed is an environmentally friendly, affordable and acceptable alternative from the point of view of regulatory requirements for the routine quality control of amlodipine medicinal products, particularly in small-scale production. |
| doi_str_mv | 10.24959/ophcj.26.346798 |
| first_indexed | 2026-04-24T01:00:13Z |
| format | Article |
| fulltext |
ISSN 2308-8303 (Print) / 2518-1548 (Online) 3
Original Research
http://ophcj.nuph.edu.ua
UDC 615.074:615.31:614.272:543.421/.424:543.42.062
O. V. Bevz1, O. V. Kryvanych2, N. Y. Bevz1, V. A. Georgiyants1
1 National University of Pharmacy of the Ministry of Health of Ukraine,
53 Hryhorii Skovoroda str., 61002 Kharkiv, Ukraine
2 State University “Uzhhorod National University”, 3 Narodna Square, 88000 Uzhhorod, Ukraine
A Universal Method for the Determination of Amlodipine
in Industrial and Extemporaneous Pharmaceutical Preparations
Abstract
A universal UV spectrophotometric method for determining amlodipine besylate in industrially manufactured and extem-
poraneously prepared medicinal products in the form of tablets, powders, and oral solutions has been developed and vali-
dated. The methodological concept is based on the use of a single analytical model applicable to various dosage forms and
dissolution media without modifying the analytical conditions. Spectral studies confirmed the presence of two absorption
maxima at (238 ± 2) nm and (365 ± 2) nm, which corresponded to different chromophoric systems of the molecule and
could be used to identify the compound; the wavelength of 365 nm was selected as the analytical wavelength, providing
improved selectivity for the quantitative determination of the active pharmaceutical ingredient. The method was validated
in accordance with pharmacopoeial requirements and ICH guidelines. The procedure is characterized by precision, accuracy,
specificity, and linearity in the range of 0.04–0.06 μg mL–1 (80–120 % of the nominal concentration) (r > 0.9981) in all solvents
proposed. The limits of detection (LOD) and quantification (LOQ) calculated were 0.59 % and 0.92 % for medicinal products
in tablet and powder dosage forms, and 0.84 % and 1.09 % for the oral solution, respectively. The uncertainty of the method,
including contributions from the sample preparation and the final analytical operation, was within acceptable limits for
spectrophotometric assay procedures. The method proved to be applicable to industrial tablets, as well as extemporaneous
powders and oral solutions, without interference from excipients in different dissolution media. Due to the minimal solvent
consumption and the absence of requirements for chromatographic equipment, the approach proposed is an environmen-
tally friendly, affordable and acceptable alternative from the point of view of regulatory requirements for the routine quality
control of amlodipine medicinal products, particularly in small-scale production.
Keywords: amlodipine besylate; pharmaceutical market analysis; market availability of medicines; UV-spectrophotometry;
standardization; quality; off-label; extemporaneous preparations
О. В. Бевз1, О. В. Криванич2, Н. Ю. Бевз1, В. А. Георгіянц1
1 Національний фармацевтичний університет Міністерства охорони здоров’я України,
вул. Григорія Сковороди, 53, м. Харків, 61002, Україна
2 ДВНЗ «Ужгородський національний університет», пл. Народна, 3, м. Ужгород, 88000, Україна
Універсальний метод визначення амлодипіну в лікарських засобах промислового
та екстемпорального виготовлення
Анотація
Розроблено та валідовано універсальну спектрофотометричну методику в ультрафіолетовому діапазоні визначення ам-
лодипіну бесилату в лікарських засобах промислового та екстемпорального виготовлення у формі таблеток, порошку
й розчину перорального. Методологічна концепція базується на використанні єдиної аналітичної моделі, застосованої
до різних лікарських форм і середовищ розчинення без модифікації аналітичних умов. Спектральні дослідження під-
твердили наявність двох максимумів поглинання за (238 ± 2) нм та (365 ± 2) нм, що відповідають різним хромофорним
системам молекули і які можна використовувати для ідентифікації сполуки. Для кількісного визначення активного
фармацевтичного інгредієнта за аналітичну довжину хвилі було обрано 365 нм, що забезпечує покращену селектив-
ність. Метод було валідовано відповідно до фармакопейних вимог та ICH. Методика характеризується точністю, пра-
вильністю, специфічністю та лінійністю в діапазоні 0.04–0.06 мкг мл–1 (80–120 % від номінальної концентрації) (r > 0,9981)
в усіх запропонованих розчинниках. Розраховані межі виявлення (LOD) та кількісного визначення (LOQ) становили
0,59 % і 0,92 % для лікарських засобів у формі таблеток і порошку, 0,84 % та 1,09 % для розчину перорального відпо-
відно. Невизначеність методики, зокрема внески від пробопідготовки зразків та кінцевої аналітичної операції, була
ISSN 2308-8303 (Print) / 2518-1548 (Online) 4
Журнал органічної та фармацевтичної хімії 2026, 24 (1)
в межах допускних значень для спектрофотометричних методик аналізу. Метод виявився застосовним до таблеток
промислового виробництва, екстемпоральних порошку та розчину для перорального застосування, без впливу до-
поміжних речовин у різних середовищах розчинення. Завдяки мінімальному споживанню розчинника та відсутності
вимог до хроматографічного обладнання запропонований підхід становить собою екологічну, доступну й прийнятну
з погляду нормативних вимог альтернативу для рутинного контролю якості лікарських засобів амлодипіну, особливо
малосерійного виробництва.
Ключові слова: амлодипіну бесилат; аналіз ринку лікарських засобів; доступність лікарських засобів на ринку; абсорбційна
спектрофотометрія в ультрафіолетовій ділянці; стандартизація; якість; оф-лейбл; екстемпоральні лікарські засоби
Citation: Bevz, O. V.; Kryvanych, O. V.; Bevz, N. Y.; Georgiyants, V. A. A Universal Method for the Determination of Amlodipine in Industrial
and Extemporaneous Pharmaceutical Preparations. Journal of Organic and Pharmaceutical Chemistry 2026, 24 (1), 3 – 12.
https://doi.org/10.24959/ophcj.26.346798
Received: 18 December 2025; Revised: 29 January 2026; Accepted: 4 February 2026
Copyright© 2026, O. V. Bevz, O. V. Kryvanych, N. Y. Bevz, V. A. Georgiyants. This is an open access article under the CC BY license
(http://creativecommons.org/licenses/by/4.0).
Funding: The authors received no specific funding for this work.
Conflict of interests: The authors have no conflict of interests to declare.
■ Introduction
Arterial hypertension (AH) and coronary heart
disease remain leading causes of premature mor-
tality in Ukraine and worldwide, which determi-
nes a high demand for modern antihypertensive
medicines [1]. One of the key medicines used in
the treatment of AH is amlodipine (amlodipine
besylate, Figure 1), a long-acting dihydropyri-
dine calcium channel antagonist characterized
by a favorable efficacy and safety profile [2, 3].
As of the time of the study (October 2025), in
Ukraine, according to the data of the State Regi-
ster of Medicines of Ukraine, 244 tablet dosage
forms containing amlodipine besylate (in terms
of amlodipine – 2.5 mg, 5 mg and 10 mg) were
registered in Ukraine and held by 36 market-
ing authorization holders. According to the ATC
classification, 42 products (17.21 %) of all posi-
tions were registered as monocomponent medi-
cines (C08CA01), 202 products (82.79 %) were
fixed-dose combination medicines [4].
The share of medicines manufactured by Ukrai-
nian companies was 29.92 %, whereas 70.08 % was
accounted for by imported products, primarily
from Slovenia, India, France, Poland, and Swit-
zerland.
Such market saturation indicates a high le-
vel of competition, a wide range of options for
physicians and patients, as well as a significant
pharmacoeconomic potential due to the availability
of medicines across both mid-priced and budget
segments.
Although, according to the official prescribing
information, the medicine is recommended for
adults and children aged 6 years and older, avail-
able studies, including physiologically based phar-
macokinetic (PBPK) modeling, clinical observa-
tions, and pharmacokinetic analyses, indicate the
possibility of its use in newborns and children
under 6 years of age, thereby confirming the
off-label use in pediatric practice [5, 6]. At the
same time, it should be considered that not all
patient populations can be adequately provided
with standard solid dosage forms due to swal-
lowing difficulties. Such groups, in addition to
newborns and young children, include elderly pa-
tients, patients with dysphagia, and bedridden
patients. This creates a need for the preparation
of medicines in pharmacies in the form of liquid
or modified dosage forms adapted to the indivi-
dual needs of specific patients.
However, ensuring the proper quality of such
medicines is complicated by the fact that pharma-
copoeial control methods [7, 8] recommended for
industrial production, in particular liquid chro-
matography, have significant limitations for the
routine use in pharmacy practice due to the re-
quirement for complex equipment, reagents, refe-
rence standards, and highly qualified personnel.
This makes the search for alternative, simpler,
and technologically accessible analytical methods
that ensure sufficient accuracy and reproducibi-
lity in the quality control of pharmacy-prepared
medicines highly relevant.
The aim of the study was to select and develop
a method for the quantitative determination of
N
H
Cl
Me
CO2Me
O
H2N
EtO2C
SO3H
Figure 1. The chemical structure of amlodipine besylate (3-Ethyl
5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-
methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate)
ISSN 2308-8303 (Print) / 2518-1548 (Online) 5
Journal of Organic and Pharmaceutical Chemistry 2026, 24 (1)
amlodipine besylate suitable for the analysis of
its dosage forms, particularly tablets and extem-
poraneous preparations in the form of powders
and oral solutions.
■ Materials and methods
The study objects were medicinal products
containing amlodipine besylate.
Industrial production:
– “Amlodipine-Astrapharm” (batch No. 010624,
Astrapharm LLC, Ukraine), tablets containing
5 mg of amlodipine with an average tablet weight
of 200 mg, formulated with calcium hydrogen
phosphate, microcrystalline cellulose, magnesium
stearate, and corn starch as excipients.
Extemporaneous production:
– “Amlodipine, 2.5 mg, powder for solution
preparation”, a powder dosage form with a unit
weight of 100 mg containing mannitol as an ex-
cipient;
– “Amlodipine, 1 mg mL–1”, oral solution, in
which 1 mL contains 1 mg of amlodipine in the
form of 1.385 mg of amlodipine besylate, glyce-
rin, maltitol, ethanol (96 %), and peppermint fla-
voring.
Experimental batches of the dosage forms in-
dicated were prepared at the Educational and Sci-
entific Training Center for Chemical and Tech-
nological Research of the Educational and Scien-
tific Institute of Applied Pharmacy of the Natio-
nal University of Pharmacy in accordance with
the requirements of Order No. 812 of the Mi-
nistry of Health of Ukraine “On Approval of the
Rules for the Preparation and Quality Control of
Medicinal Products in Pharmacies”, taking into
account the requirements of the State Pharma-
copoeia of Ukraine and the United States Phar-
macopeia (USP) [9, 10, 11].
For the preparation of experimental samples
and reference solutions, the following materials
were used: amlodipine besylate (99.94 %, batch
No. AMV/016/01/19, Glochem Industries Limi-
ted, India); ethyl alcohol (96 %, batch No. 120525,
Biolik PJSC, Ukraine); glycerin (99.5 %, batch
No. 5602/432/1223, Agrohim Trading House,
Ukraine); crystalline maltitol (99.1 %, batch
No. 2023050720, Shandong Lujian Biological
Technology Co., Ltd., China); mannitol 200 SD
(99.9 %, batch No. 200SD2209003, Shijiazhuang
Huaxu Pharmaceutical Co., Ltd., China); micro-
crystalline cellulose (batch No. 20240203, Hu-
zhou City Lingha Xinwang Chemical Co., Ltd.,
China); anhydrous dicalcium phosphate (99.9 %,
batch No. 2428332, Prayon S.A., USA); potato
starch (batch No. 29.10.2024, VYMAL PE, Ukrai-
ne) and magnesium stearate (batch No. MS-019,
0, Ukraine).
To develop a method for the quantitative de-
termination of amlodipine besylate, absorption
spectrophotometry in the ultraviolet and visible
regions (SPhU 2.2.25N / Ph. Eur. 2.2.25) was em-
ployed [7, 12]. The study was performed using
a SHIMADZU UV-2600 spectrophotometer equip-
ped with UV-Probe software version 2.33.
The sample preparation was performed us-
ing AXIS analytical balances and Class A volu-
metric glassware. All reagents and titrated so-
lutions used met the relevant pharmacopoeial
requirements [7, 9].
Solvents: 0.1 M hydrochloric acid, 0.1 M so-
dium hydroxide or ethanol (96 %).
Test solution. A mass (or volume) of the me-
dicinal product equivalent to 2.5 mg of amlodi-
pine (accurately weighed) is placed into a 50.0 mL
volumetric flask, 30 mL of the solvent is added,
the mixture is shaken for 10 min, diluted to the
volume with the same solvent, and filtered if ne-
cessary.
Reference solution. An accurately weighed
amount of amlodipine besylate equivalent to
50.0 mg of amlodipine is dissolved in 30 mL of the
solvent, and the solution is diluted to 100.0 mL
with the same solvent and mixed. Then, 5.0 mL of
the resulting solution is transferred to a 50.0 mL
volumetric flask and diluted to the volume with
the same solvent.
Placebo solution. It is prepared using the same
excipients in amounts corresponding to those used
for Test solution without the addition of the ac-
tive pharmaceutical ingredient.
Compensation solution. It is the solvent.
■ Results and discussion
According to published data, several liquid
chromatography methods have been proposed
for the determination of amlodipine besylate in
pharmaceutical substances and medicinal pro-
ducts. In addition to the pharmacopoeial sepa-
ration conditions on the octadecylsilyl silica gel
column (250 × 4.0 mm, 5 μm) using the mobile
phase of ammonium acetate (2.3 g L–1) and me-
thanol in the ratio of 30:70 (v/v) and detection at
237 nm [7, 8], the determination of the active phar-
maceutical ingredient was also carried out using
a C18 core-shell column (100 × 4.6 mm, 2.6 μm) and
the mobile phase consisting of 0.4 % ammonium
ISSN 2308-8303 (Print) / 2518-1548 (Online) 6
Журнал органічної та фармацевтичної хімії 2026, 24 (1)
hydroxide solution in water and methanol in the
gradient mode [13], as well as by liquid chroma-
tography with the mass detection on a ZORBAX
Eclipse Plus C18 column using the mobile phase
of methanol – aqueous formic acid (5 mM) in the
ratio of 95:5 (v/v) [14]. At the same time, a signi-
ficant part of the research focused on alternative
spectrophotometric methods for the determina-
tion of amlodipine besylate based on its intrinsic
light absorption, particularly in methanolic me-
dia where analytical wavelengths in the range
of 238 – 244 nm were commonly applied [15, 16],
as well as in acidic media, such as 0.1 M hy-
drochloric acid, in which the determination was
performed at 239 nm [17]. In addition, methods
based on the formation of colored reaction prod-
ucts with dyes were described, including amido
black with an absorption maximum at 592 nm
[18] and sodium 1,2-naphthoquinone-4-sulfona-
te in the alkaline medium with an absorption
maximum at 459 nm [19].
Considering current trends in the develop-
ment of analytical chemistry, the concept of
Green Analytical Chemistry is gaining increas-
ing attention. It involves minimizing the use of
toxic reagents and organic solvents, reducing
waste generation, energy saving, and simplifying
analytical procedures [20, 21]. To support the me-
thod selection, a preliminary assessment of the
environmental friendliness of literature-reported
methods used for the analysis of amlodipine be-
sylate was carried out (Figure 2).
The results obtained (Figure 2) clearly de-
monstrate that spectrophotometric methods (Fi-
gures 2B and 2C) have significant advantages
over the pharmacopoeial chromatographic me-
thod (Figure 2A) as they do not require large
volumes of organic solvents, complex high-cost
and energy-consuming equipment, and are cha-
racterized by the shorter analysis time. These ad-
vantages make spectrophotometric methods suit-
able for the routine quality control of medicinal
products, particularly under conditions of pharma-
cy compounding and industrial manufacturing.
The analysis of literature sources reveals the
absence of the system approach to substantiat-
ing the choice of analytical wavelengths for the
determination of amlodipine besylate, as well as
the insufficient comprehensive validation of the
corresponding methods. Therefore, the present
study proposes an approach aimed at the scien-
tifically justified selection of specific analytical
wavelengths, their experimental confirmation,
and full validation in accordance with current
regulatory requirements [9].
At the first stage of the study, the spectral cha-
racteristics of amlodipine besylate were investi-
gated in three different dissolution media: etha-
nol (96 %), 0.1 M sodium hydroxide, and 0.1 M
hydrochloric acid (Figure 3).
As shown in Figure 3, the absorption spec-
tra of the test compound, regardless of the dis-
solution medium, are characterized by the pres-
ence of two absorption maxima at wavelengths
of (238 ± 2) nm and (365 ± 2) nm.
It should be noted that the absorption maxi-
mum near 238 nm was used only for spectral cha-
racterization of the substance. This band is asso-
ciated with the presence of aromatic and pyri-
dine chromophores in the amlodipine molecule, as
well as the benzenesulfonate moiety. In contrast,
the absorption maximum at 365 nm is attributed
predominantly to the amlodipine base. There-
fore, it was selected as the analytical wavelength
A B C
Figure 2. The AGREE analytical scale of amlodipine besylate studies: (A) by liquid chromatography according to the method described
in the monograph of the European Pharmacopoeia [7]; (B) by Vis-spectrophotometry based on dye–reagent reactions [18, 19];
(C) by UV-spectrophotometry based on the intrinsic light absorption of the compound [15, 16, 17].
ISSN 2308-8303 (Print) / 2518-1548 (Online) 7
Journal of Organic and Pharmaceutical Chemistry 2026, 24 (1)
for the quantitative determination of the active
pharmaceutical ingredient in medicinal products.
Quantitative measurements were performed
at 365 nm where the absorbance values of work-
ing solutions were within the optimal instru-
mental range (A = 0.6 – 0.8), complying with
Beer–Lambert law requirements.
The methodological distinction of the approach
proposed from previously reported UV spectro-
photometric procedures lies not only in the se-
lection of the analytical wavelength, but in the
concept of a unified assay model. The method was
developed as a single analytical platform appli-
cable to different dosage forms (industrial tab-
lets, pharmacy-compounded powders and oral so-
lutions) and different dissolution media without
modifying the analytical conditions. In contrast,
most published UV methods are optimized for
one formulation type or one solvent system.
The present study, therefore, demonstrates the
transferability and robustness of a single spectro-
photometric model across pharmaceutical mat-
rices, which is essential for the routine quality
control in pharmacy compounding practice.
However, it is worth noting that during the
dissolution in 0.1 M sodium hydroxide, the sub-
stance clumps together, so for its dissolution it is
necessary to use an ultrasonic device or dissolve
with intensive stirring. In the medium of 0.1 M
hydrochloric acid, the dissolution process lasts
at least 10 minutes. But the methods have good
convergence of results, so they can be transfer-
red to determine the API in the composition of me-
dicines, regardless of the form of release. The Beer–
Lambert law is obeyed in all solvents within the
concentration range of 0.02 – 0.7 µg mL–¹.
For further application of the method for the
quantitative determination of API in the compo-
sition of the medicines studied, the characteris-
tics of the spectra of drug solutions and placebo
solutions in different dissolution media were stud-
ied (Figures 4 – 6).
As shown in Figures 4 – 6, the method is not
affected by systematic error caused by excipients,
indicating that the method is specific for the de-
termination of amlodipine in the objects studied.
The method demonstrated linearity (Table 1)
in the concentration range of 0.04 – 0.06 µg mL–1
(corresponding to 80 – 120 % of the nominal concen-
tration), with correlation coefficients r > 0.9981
in all media.
Although the determination of detection and
quantification limits were not mandatory for as-
say methods intended for the quantitative de-
termination of active substances in finished dos-
age forms, these parameters were additionally
estimated to further characterize the analytical
performance of the method proposed.
The detection limit (LOD) and quantification
limit (LOQ) for amlodipine besylate were calculat-
ed using the standard ICH Q2 and the SPhU ap-
proach based on regression parameters (Sa and b):
LOD = 3.3·Sa∙b–1; LOQ = 10·Sa∙b–1 (Table 1).
Both values are substantially lower than the
lower limit of the validated concentration range,
indicating that the working assay concentra-
tions are well above the quantification limit.
Therefore, the sensitivity characteristics of the
method do not limit its accuracy or applicability
for the quantitative determination.
As can be seen from Table 2, the analysis
method is correct and is characterized by sufficient
0 0.
0 5.
1 0.
1 5.
2 0.
2 5.
3 0.
220 240 260 280 300 320 340 360 380 400
1 2 3
А
λ, nm
Figure 3. Absorption spectra of the amlodipine besylate reference solution (the amlodipine concentration – 0.05 µg mL–1) in ethanol
(96 %) (1), 0.1 M hydrochloric acid (2) and 0.1 M sodium hydroxide (3)
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convergence and accuracy in the entire concen-
tration range of 80 – 120 %.
The uncertainty associated with the sample
preparation for the quantitative determination was
evaluated in accordance with the requirements
of the State Pharmacopoeia of Ukraine [12].
The total uncertainty (ΔAs, r) of the analysis
was calculated using the expression:
� �As, r �
SP
2
�
FAO
2
� max�As � 1.6√ �
where ΔSP is the uncertainty contribution of the sam-
ple preparation operations, and ΔFAO is the uncer-
tainty contribution of the final analytical operation.
For medicinal products in the form of tablets
and powders, the uncertainty of the sample pre-
paration was:
�SP, r �
� 1.60.59 <
√(0.2
2
� 0.17 ) (0.33 0.12 0.37 0.17 )
2 2 2 2 2
� � � � �
For medicinal products in the form of the oral
solution, the uncertainty of the sample prepara-
tion was:
�SP, r �
� 1.60.84 <
√(0.62
2
� 0.17 ) (0.33 0.12 0.37 0.17 )
2 2 2 2 2
� � � � �
0 0.
0 5.
1 0.
1 5.
2 0.
2 5.
3 0.
220 240 260 280 300 320 340 360 380 400
1 2 3 4 5 6 λ, nm
А
Figure 4. Absorption spectra of solutions of the drug “Amlodipine-Astrapharm” (the amlodipine concentration – 0.05 µg mL–1) and
placebo in ethanol (96 per cent) (1) and (2), 0.1 M hydrochloric acid (3) and (4), 0.1 M sodium hydroxide (5) and (6), respectively
0 0.
0 5.
1 0.
1 5.
2 0.
2 5.
3 0.
220 240 260 280 300 320 340 360 380 400
1 2 3 4 5 6
λ, nm
А
Figure 5. Absorption spectra of solutions of the drug “Amlodipine. 2.5 mg, powder for solution preparation” (the amlodipine
concentration – 0.05 µg mL–1) and placebo in ethanol (96 per cent) (1) and (2), 0.1 M hydrochloric acid (3) and (4), 0.1 M sodium
hydroxide (5) and (6), respectively
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Journal of Organic and Pharmaceutical Chemistry 2026, 24 (1)
220 240 260 280 300 320 340 360 380 400
1 2 3 4 5 6
А
λ, nm0 0.
0 5.
1 0.
1 5.
2 0.
2 5.
3 0.
Figure 6. Absorption spectra of solutions of the drug “Amlodipine, 1 mg mL–1, oral solution” (the amlodipine concentration – 0.05 µg mL–1)
and placebo in ethanol (96 %) (1) and (2), 0.1 M hydrochloric acid (3) and (4), 0.1 M sodium hydroxide (5) and (6), respectively
Table 1. Metrological characteristics of the linear relationship between the measured concentration of amlodipine and its nominal
concentration in normalized coordinates
Parameters Value
Acceptance
criteria ConclusionsDissolution
medium Ethanol (96 %) 0.1 M hydrochloric
acid
0.1 M sodium
hydroxide
“Amlodipine-Astrapharm”, tablets
b 0.9940 0.9950 1.0031
Sb 0.0093 0.0103 0.0054
a 0.8378 0.7033 0.4067 ≤ 2.60 Meets acceptance criteria
Sa 0.9359 1.0373 0.5443
S0 0.3595 0.3984 0.2091 ≤ 0.845 Meets acceptance criteria
r 0.9997 0.9996 0.9999 > 0.9981 Meets acceptance criteria
LOD 3.11 3.44 1.79 < 32 % Meets acceptance criteria
LOQ 9.42 10.43 5.43 < 32 % Meets acceptance criteria
“Amlodipine, 2.5 mg, powder for solution preparation”
b 0.9873 0.9983 0.9966
Sb 0.0144 0.0025 0.0044
a 1.2511 0.2289 0.4633 ≤ 2.60 Meets acceptance criteria
Sa 1.4478 0.2472 0.4426
S0 0.5561 0.0949 0.1700 ≤ 0.845 Meets acceptance criteria
r 0.9992 1.0000 0.9999 > 0.9981 Meets acceptance criteria
LOD 4.83 0.82 1.47 < 32 % Meets acceptance criteria
LOQ 14.66 2.48 4.44 < 32 % Meets acceptance criteria
“Amlodipine, 1 mg mL–1, oral solution”
b 0.9968 0.9980 0.9971
Sb 0.0054 0.0062 0.0031
a 0.4444 0.3622 0.3944 ≤ 2.60 Meets acceptance criteria
Sa 0.5425 0.6261 0.3078
S0 0.2084 0.2405 0.1182 ≤ 0.8450 Meets acceptance criteria
r 0.9999 0.9998 1.0000 > 0.9981 Meets acceptance criteria
LOD 1.80 2.07 1.02 < 32 % Meets acceptance criteria
LOQ 5.44 6.27 3.09 < 32 % Meets acceptance criteria
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The values obtained are significantly lower
than the maximum permissible uncertainty, con-
firming that the sample preparation does not in-
troduce a critical contribution to the overall
measurement uncertainty of the method.
According to the recommendations of the
SPhU general chapter 5.3.N.2 “Validation of ana-
lytical procedures and tests” [12], the uncertain-
ty of the final analytical operation for the spec-
trophotometric analysis using the standard me-
thod is 0.70 %.
The total predicted uncertainty of the assay
procedure was calculated according to equation:
for medicinal products in the form of tablets
and powders:
� , rAs � √(0.59
2
� 0.70 ) 0.92 1.6
2
� �
for medicinal products in the form of the oral
solution:
� , rAs � √(0.84
2
� 0.70 ) 1.09 1.6
2
� �
The values calculated demonstrate that the
overall uncertainty of the spectrophotometric me-
thod developed for the quantitative determina-
tion of the finished medicinal product by the stan-
dard method complies with the recommendations
of the general chapter 5.3.N.2 “Validation of ana-
lytical procedures and tests”.
The validated method was transferred to the
quantitative determination of API in the study
objects (Table 3).
The results of the quantitative determination
of the active pharmaceutical ingredient in the ob-
jects studied were independent of the dissolution
medium, showed no significant systematic error,
and were consistent with the declared content of
the medicinal products.
The practical significance of the method lies
in its applicability not only to the quality con-
trol of industrially manufactured medicinal pro-
ducts, but also for extemporaneous preparations.
Compared with pharmacopoeial chromatographic
Table 2. Results of the accuracy and precision assessment
Parameters Value
Requirements
for statistical
non-significance
Requirements
for practical
significance
ConclusionDissolution
medium
Ethanol
(96 per cent)
0.1 M
hydrochloric
acid
0.1 M sodium
hydroxide
“Amlodipine-Astrapharm”, tablets
|Z – 100| 0.25 0.22 0.12 ≤ 0.35 ≤ 0.51 Performed according
to two criteria
Δintra 0.77 0.86 0.42 ≤ 1.6 – Сonducted
“Amlodipine, 2.5 mg, powder for solution preparation”
|Z – 100| 0.00 0.06 0.13 ≤ 0.35 ≤ 0.51 Performed according
to two criteria
Δintra 1.19 0.20 0.36 ≤ 1.6 – Сonducted
“Amlodipine, 1 mg mL–1, oral solution”
|Z – 100| 0.13 0.17 0.12 ≤ 0.35 ≤ 0.51 Performed according
to two criteria
Δintra 0.42 0.50 0.27 ≤ 1.6 – Сonducted
Table 3. Results of the quantitative determination of APIs in medicinal products
Dissolution media
Weight of the
sample (volume)
of the drug, g (mL)
A
(average of
3 measurements)
Weight of
amlodipine
besylate
Ао
The quantitative
content of
amlodipine, mg
“Amlodipine-Astrapharm”, tablets
Ethanol (96 %) 0.1025 0.762 0.0694 0.890 0.0052
0.1 M hydrochloric acid 0.1007 0.737 0.0632 0.810 0.0051
0.1 M sodium hydroxide 0.1004 0.740 0.0676 0.867 0.0051
“Amlodipine, 2.5 mg, powder for solution preparation”
Ethanol (96 %) 0.1017 0.659 0.0694 0.890 0.0025
0.1 M hydrochloric acid 0.1029 0.67 0.0632 0.810 0.0025
0.1 M sodium hydroxide 0.1008 0.655 0.0676 0.867 0.0025
“Amlodipine, 1 mg mL–1”, oral solution
Ethanol (96 %) 2.5 0.678 0.0694 0.890 0.0011
0.1 M hydrochloric acid 2.5 0.665 0.0632 0.810 0.0010
0.1 M sodium hydroxide 2.5 0.671 0.0676 0.867 0.0010
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Journal of Organic and Pharmaceutical Chemistry 2026, 24 (1)
methods, the approach proposed is simpler, more
accessible, and less resource-intensive, making
it suitable for implementation in pharmacy prac-
tice and small analytical laboratories.
Thus, it can be stated that the spectrophoto-
metric method developed is a reliable, reproduc-
ible and cost-effective alternative for controlling
the content of amlodipine besylate in medicinal
products in various dissolution media by its own
light absorption.
■ Conclusions
The features of the market of medicinal
products containing amlodipine besylate have
been identified, and the need for alternative con-
trol methods for pharmacy-compounded dosage
forms has been determined due to the limited
feasibility of full-scale application of pharma-
copoeial chromatographic methods in routine
practice.
It has been found that the absorption spectra
of the test compound, regardless of the dissolution
medium, are characterized by the presence of two
absorption maxima at wavelengths (238 ± 2) nm
and (365 ± 2) nm, which can be used for identifi-
cation purposes. The wavelength of (365 ± 2) nm
was selected as the analytical wavelength for
the quantitative determination of amlodipine in
the substance and medicinal products.
The spectrophotometric method proposed for
the quantitative determination of amlodipine be-
sylate has been validated; the procedure is cha-
racterized by precision, accuracy, specificity, and
linearity in the range of 0.04 – 0.06 μg mL–1
(80 – 120 % of the nominal concentration) (r > 0.9981)
in all solvents proposed.
The limits of detection (LOD) and quantification
(LOQ) calculated are 0.59 % and 0.92 % for medici-
nal products in tablet and powder dosage forms, and
0.84 % and 1.09 % for the oral solution, respectively.
The uncertainty of the method, including con-
tributions from the sample preparation and the
final analytical operation, was within acceptable
limits for spectrophotometric assay procedures.
It has been determined that the results of the
quantitative determination of amlodipine in tab-
lets, powder and oral solution correspond to the
declared content and are convergent, regardless
of the dissolution medium.
The study demonstrates that UV spectropho-
tometry when methodologically optimized remains
a scientifically justified and regulatory-acceptable
alternative to chromatographic techniques for the
routine assay of amlodipine in diverse pharma-
ceutical preparations.
■ References
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1&gclid=CjwKCAjwrvyxBhAbEiwAEg_KggM2vAWActF3ldiwk_7moMRXYNPSu03MfdYQUo_oug2yupCVqPirWxoCE2EQAvD_BwE
(accessed 2025-10-02).
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facture and Quality Control of Medicinal Products in Pharmacies”, in Ukrainian]. https://zakon.rada.gov.ua/laws/show/z1846-12#Text.
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macopeial Convention: Rockville, MD, 2023.
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Information about the authors:
Olena V. Bevz (corresponding author), PhD in Pharmacy, Associate Professor, doctoral student, Department of Pharmaceutical Chemistry,
National University of Pharmacy of the Ministry of Health of Ukraine; https://orcid.org/0000-0002-7695-3612;
e-mail for correspondence: bevz.helen@gmail.com.
Oleksandr V. Kryvanych, PhD in Pharmacy, Associate Professor, Department of Pharmaceutical Disciplines, Uzhhorod National University;
https://orcid.org/0000-0001-7311-1543.
Nataliia Yu. Bevz, PhD in Pharmacy, Associate Professor, Department of Pharmaceutical Chemistry, National University of Pharmacy
of the Ministry of Health of Ukraine; http://orcid.org/0000-0002-7259-8908.
Victoriya A. Georgiyants, Doctor of Pharmacy, Professor, Head of the Department of Pharmaceutical Chemistry, National University
of Pharmacy of the Ministry of Health of Ukraine; http://orcid.org/0000-0001-8794-8010.
|
| id | oai:ojs.journals.uran.ua:article-346798 |
| institution | Journal of Organic and Pharmaceutical Chemistry |
| issn | 2518-1548 |
| keywords_txt_mv | |
| language | English |
| last_indexed | 2026-08-25T01:02:50Z |
| publishDate | 2026 |
| publisher | National University of Pharmacy |
| record_format | ojs |
| resource_txt_mv | ophcjnupheduua/c3/fbfe8953f7b35bbe60e203d319847ec3.pdf |
| spelling | oai:ojs.journals.uran.ua:article-3467982026-08-24T19:33:19Z A Universal Method for the Determination of Amlodipine in Industrial and Extemporaneous Pharmaceutical Preparations Універсальний метод визначення амлодипіну в лікарських засобах промислового та екстемпорального виготовлення Bevz, Olena V. Kryvanych, Oleksandr V. Bevz, Nataliia Yu. Georgiyants, Victoriya A. amlodipine besylate pharmaceutical market analysis market availability of medicines UV-spectrophotometry standardization quality off-label extemporaneous preparations амлодипіну бесилат аналіз ринку лікарських засобів доступність лікарських засобів на ринку абсорбційна спектрофотометрія в ультрафіолетовій ділянці стандартизація якість оф-лейбл екстемпоральні лікарські засоби A universal UV spectrophotometric method for determining amlodipine besylate in industrially manufactured and extemporaneously prepared medicinal products in the form of tablets, powders, and oral solutions has been developed and validated. The methodological concept is based on the use of a single analytical model applicable to various dosage forms and dissolution media without modifying the analytical conditions. Spectral studies confirmed the presence of two absorption maxima at (238 ± 2) nm and (365 ± 2) nm, which corresponded to different chromophoric systems of the molecule and could be used to identify the compound; the wavelength of 365 nm was selected as the analytical wavelength, providing improved selectivity for the quantitative determination of the active pharmaceutical ingredient. The method was validated in accordance with pharmacopoeial requirements and ICH guidelines. The procedure is characterized by precision, accuracy, specificity, and linearity in the range of 0.04–0.06 μg mL-1 (80–120% of the nominal concentration) (r &gt; 0.9981) in all solvents proposed. The limits of detection (LOD) and quantification (LOQ) calculated were 0.59% and 0.92% for medicinal products in tablet and powder dosage forms, and 0.84% and 1.09% for the oral solution, respectively. The uncertainty of the method, including contributions from the sample preparation and the final analytical operation, was within acceptable limits for spectrophotometric assay procedures. The method proved to be applicable to industrial tablets, as well as extemporaneous powders and oral solutions, without interference from excipients in different dissolution media. Due to the minimal solvent consumption and the absence of requirements for chromatographic equipment, the approach proposed is an environmentally friendly, affordable and acceptable alternative from the point of view of regulatory requirements for the routine quality control of amlodipine medicinal products, particularly in small-scale production. Розроблено та валідовано універсальну спектрофотометричну методику в ультрафіолетовому діапазоні визначення амлодипіну бесилату в лікарських засобах промислового та екстемпорального виготовлення у формі таблеток, порошку й розчину перорального. Методологічна концепція базується на використанні єдиної аналітичної моделі, застосованої до різних лікарських форм і середовищ розчинення без модифікації аналітичних умов. Спектральні дослідження підтвердили наявність двох максимумів поглинання за (238 ± 2) нм та (365 ± 2) нм, що відповідають різним хромофорним системам молекули і які можна використовувати для ідентифікації сполуки. Для кількісного визначення активного фармацевтичного інгредієнта за аналітичну довжину хвилі було обрано 365 нм, що забезпечує покращену селективність. Метод було валідовано відповідно до фармакопейних вимог та ICH. Методика характеризується точністю, правильністю, специфічністю та лінійністю в діапазоні 0.04–0.06 мкг мл-1 (80–120% від номінальної концентрації) (r &gt; 0,9981) в усіх запропонованих розчинниках. Розраховані межі виявлення (LOD) та кількісного визначення (LOQ) становили 0,59% і 0,92% для лікарських засобів у формі таблеток і порошку, 0,84% та 1,09% для розчину перорального відповідно. Невизначеність методики, зокрема внески від пробопідготовки зразків та кінцевої аналітичної операції, була в межах допускних значень для спектрофотометричних методик аналізу. Метод виявився застосовним до таблеток промислового виробництва, екстемпоральних порошку та розчину для перорального застосування, без впливу допоміжних речовин у різних середовищах розчинення. Завдяки мінімальному споживанню розчинника та відсутності вимог до хроматографічного обладнання запропонований підхід становить собою екологічну, доступну й прийнятну з погляду нормативних вимог альтернативу для рутинного контролю якості лікарських засобів амлодипіну, особливо малосерійного виробництва. National University of Pharmacy 2026-05-04 Article Article application/pdf https://ophcj.nuph.edu.ua/article/view/346798 10.24959/ophcj.26.346798 Journal of Organic and Pharmaceutical Chemistry; Vol. 24 No. 1 (2026); 3-12 Журнал органической и фармацевтической химии; Том 24 № 1 (2026); 3-12 Журнал органічної та фармацевтичної хімії; Том 24 № 1 (2026); 3-12 2518-1548 2308-8303 en https://ophcj.nuph.edu.ua/article/view/346798/344296 Copyright (c) 2026 Olena V. Bevz, Oleksandr V. Kryvanych, Nataliia Yu. Bevz, Victoriya A. Georgiyants http://creativecommons.org/licenses/by/4.0 |
| spellingShingle | амлодипіну бесилат аналіз ринку лікарських засобів доступність лікарських засобів на ринку абсорбційна спектрофотометрія в ультрафіолетовій ділянці стандартизація якість оф-лейбл екстемпоральні лікарські засоби Bevz, Olena V. Kryvanych, Oleksandr V. Bevz, Nataliia Yu. Georgiyants, Victoriya A. Універсальний метод визначення амлодипіну в лікарських засобах промислового та екстемпорального виготовлення |
| title | Універсальний метод визначення амлодипіну в лікарських засобах промислового та екстемпорального виготовлення |
| title_alt | A Universal Method for the Determination of Amlodipine in Industrial and Extemporaneous Pharmaceutical Preparations |
| title_full | Універсальний метод визначення амлодипіну в лікарських засобах промислового та екстемпорального виготовлення |
| title_fullStr | Універсальний метод визначення амлодипіну в лікарських засобах промислового та екстемпорального виготовлення |
| title_full_unstemmed | Універсальний метод визначення амлодипіну в лікарських засобах промислового та екстемпорального виготовлення |
| title_short | Універсальний метод визначення амлодипіну в лікарських засобах промислового та екстемпорального виготовлення |
| title_sort | універсальний метод визначення амлодипіну в лікарських засобах промислового та екстемпорального виготовлення |
| topic | амлодипіну бесилат аналіз ринку лікарських засобів доступність лікарських засобів на ринку абсорбційна спектрофотометрія в ультрафіолетовій ділянці стандартизація якість оф-лейбл екстемпоральні лікарські засоби |
| topic_facet | amlodipine besylate pharmaceutical market analysis market availability of medicines UV-spectrophotometry standardization quality off-label extemporaneous preparations амлодипіну бесилат аналіз ринку лікарських засобів доступність лікарських засобів на ринку абсорбційна спектрофотометрія в ультрафіолетовій ділянці стандартизація якість оф-лейбл екстемпоральні лікарські засоби |
| url | https://ophcj.nuph.edu.ua/article/view/346798 |
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