Фармацевтика Аналитика Акта

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Stability Indicating Reverse Phase Chromatographic Method for Estimation of Related Substances in Voriconazole Drug Substance by Ultra Performance Liquid Chromatography

Maheswara Reddy Musirike, Hussain Reddy K and Useni Reddy Mallu

A simple, sensitive and accurate analytical method for related substances of Voriconazole has been developed and validated by using RP-UPLC technique. The developed analytical procedure was validated as per ICH recommendations. Analysis was performed on a HALO C18 (100 × 2.1 2.7 μ) column. 20 mM ammonium formate adjusted the pH to 4.5 with formic acid was selected as buffer. Acetonitrile was used as organic modifier in the mobile phase composition. A simple gradient was applied in the method. Flow rate of mobile phase was kept at 0.4 ml per min. Column compartment temperature was maintained at 45°C. Injection volume was set at 1 μL with an auto sampler maintained the temperature at 10°C. Detection of all the components was monitored at 254 nm by photodiode array detector. Developed method satisfies the system suitability criteria, peak integrity, and resolution for the parent drug and its related substances. The proposed method was validated for Specificity, precision, accuracy, linearity, limit of detection and quantification. Forced degradation studies were conducted to assess stability indicating nature of the method under acidic, basic, oxidative and photolytic conditions. Run time less than 7.0 minutes indicating that the method is cost effective and productive; it can be successfully applied for testing of related substances in drug substance and assay of drug substance in routine quality control analysis and stability testing.