Validation of Quantitative Determination Methods for Fexofenadine Hydrochloride and Cyanocobalamine in Separate Ophthalmological Dosage Forms Using UV-Spectrophotometry Instrumentation

摘要

Aim of this study is validation of quantitative determination methods for Fexofenadine hydrochloride, Cyanocobalamine in separate ophthalmological dosage forms using UV-spectrophotometry instrumentation. Assay tests of the studied ophthalmological dosage forms were carried out using the APIs and reagents of pharmaceutical grade. As APIs, Fexofenadine hydrochloride, Cyanocobalamine were chosen. For dilution of Fexofenadine hydrochloride dosage form, 5% solution of sodium hydroxide and purified water were used. Solution of cyanocobalamine was diluted by purified water. Spectrophotometer SF-104 was used in this study, manufactured in Russia by Akvilon SZ Company. Spectrophotometric cells with optical path length of 10 mm were used for all the measurements. By the obtained experimental data it was established that the proposed assay methods for Fexofenadine hydrochloride and Cyanocobalamine ophthalmological solutions are reliable and valid. The new methods for Fexofenadine hydrochloride and Cyanocobalamine ophthalmological solutions were proposed and successfully validated in from the perspective of specificity, linearity, analytical range, correctness and repeatability.