Валідація методики кількісного визначення гідрохлоротіазиду в екстемпоральних лікарських засобах

• Дата: 2017
• Автори: Ugbenbo, D. Alfred, Zdoryk, O. A., Bevz, N. Yu., Georgiyants, V. A.
• Формат: Стаття
• Мова: English
• Опубліковано: National University of Pharmacy 2017
• Теми: Hydrochlorothiazide; UV-spectrophotometry; validation of the analytical method; extemporaneous preparations; UDC 615.22; 615.254; 615.451.2; 54.062; 543.068; гидрохлортиазид; УФ-спектрофотометрия; валидация аналитических методик; экс- темпоральные лекарственные средства; УДК 615.22; гідрохлоротіазид; УФ-спектрофотометрія; валідація аналітичних методик; екстемпоральні лікарські засоби
• Онлайн доступ: https://ophcj.nuph.edu.ua/article/view/ophcj.17.915
• Назва журналу: Journal of Organic and Pharmaceutical Chemistry

Extemporaneous preparations that contain hydrochlorothiazide are widely prescribed and used in different countries for treating adults and children. The feature of the preparation of such dosage forms is the use of substances and commercial drugs as a source of the active pharmaceutical ingredient.Aim. To validate the UV-spectroscopic assay method for determining hydrochlorothiazide in extemporaneous syrups and powders.Results and discussion. For method proposed the conditions of analysis, sample preparation and validation characteristics were determined. The samples of syrups and the powder were dissolved in 0.01 M sodium hydroxide solution and assessed by spectrophotometry in the ultraviolet region of light at the wavelength of 273 nm. The samples comply with the Beer-Lambert Bouguer law within the concentration range of 8 × 10-3-1.2 × 10-2 mg/ml with the the correlation coefficients ≥ 0.9992. The uncertainty of the methods was within the critical value of the error (the powder – 1.14 %, the syrup – 0.72 %) for both samples of the syrup containing the pure substance and commercial tablets. The assay method of hydrochlorothiazide in the extemporaneous preparations meets the acceptance criteria for the assay limits of ± 7.5 % and ± 10 % by such validation parameters as specificity, linearity, precision, accuracy within the range of 80-120 % of the nominal content.Experimental part. For research the volumetric glassware Class A, an UV-spectrophotometer (Thermoscientific Evolution 60S), analytical balances (AXIS ALN220), reagents and solvents corresponding to the requirements of the State Pharmacopoeia of Ukraine were used.Conclusions. The validation results have proven that the method can be reproduced correctly and is suitable for use in pharmaceutical analysis.