Simultaneous estimation of new analytical method development and validation of atazanavir and cobicistat by high performance liquid chromatography

Abstract

A simple, specific, precise, and efficient method for the Simultaneous estimation of Cobicistat and Atazanavir in pure and pharmaceutical dosage forms by a Reverse Phase-High Performance Liquid Chromatography method is developed and validated. Selected mobile phase were in a combination of ACN, Methanol and Phosphate buffer pH4.6 (10:25:65 v/v). Optimized column is a Develosil C18 (4.6mm×250mm) 5µm particle size and at a flow rate of 1.0mL/min with detection wavelength at 238nm for Cobicistat and Atazanavir. In our study, the validation of analytical method for determination of Cobicistat and Atazanavir in pure and pharmaceutical dosage forms was performed in accordance the parameters including-system suitability, specificity, linearity of response, accuracy, precision (reproducibility & repeatability), robustness (change of wave length±2 nm). The method is validated according to ICH guidelines. The results obtained by RP-HPLC methods are rapid, accurate and precise. Therefore proposed method can be used for routine analysis of Cobicistat and Atazanavir in the pure form as well as in combined pharmaceutical dosage form.