Розробка та валідація методики визначення супровідних домішок у таблетках рибоксин

• Date: 2015
• Main Authors: Rosada, M. V., Bevz, N. Yu., Georgiyants, V. A.
• Format: Article
• Language: English
• Published: National University of Pharmacy 2015
• Subjects: стандартизація; рибоксин; таблетки; супровідні домішки; метод ВЕРХ; УДК 615.22; 615.453.6; 543.544.5.068.7; 543.05
• Online Access: https://ophcj.nuph.edu.ua/article/view/ophcj.15.863
• Journal Title: Journal of Organic and Pharmaceutical Chemistry

Riboxin (inosine) is used in medicine for treating cardiovascular diseases, so the number of dosage forms containing this substance as an active ingredient is constantly increasing at the Ukrainian pharmaceutical market. When developing quality control methods for a dosage form containing one active substance it is advisable to carry out tests on the presence of related impurities besides identification and assay tests. The article presents the data concerning development of the method for determination of related impurities (hypoxanthine, guanosine) in riboxine tablets using HPLC. The analysis was carried out using a HPLC column (125×4 mm i.d., 5 μm particles) filled with “Lichrospher 60 RP select B”sorbent. The mobile phase adjusted with the phosphate buffer to pH 3.5 was used. The UV detection was performed at 250 nm. The validation characteristics have been studied using the acceptance criteria for the tolerances of the content not more than 0.5% for each impurity, and they confirm specificity (the absence of the effect of excipients), linearity, precision (convergence), accuracy (Δz = 0.79≤max Δz = 5.0, δ = 0.21≤max δ = 0.26, a = 0.48, r = 0.99997>0.9976 for hypoxanthine, and Δz = 0.83≤max Δz = 5.0, δ = 0.17≤max δ = 0.28, a = 0.21, r = 0.99997>0.9976 for guanosine), and the application range for the method proposed.