Abstract
NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANIOUS ESTIMATION AND FORCED DEGRADATION STUDIES OF COBICISTAT AND ATAZANAVIR IN TABLET DOSAGE FORM

K. Renuka*, P. Sunitha and Dr. Vijaya Kuchana

ABSTRACT

Objective: A New method was established for simultaneous estimation of Cobicistat and Atazanavir by RP-HPLC method and Its force degradation study. Methods: Chromatographic separations were carried using inertsil (ODS 250 x 4.6 mm, 5.), column with a mobile phase composition of 0.1 M Na2HPO4 (45) and ACN (55%).have been delivered at a flow rate of 1ml/min and the detection was carried out using waters HPLC auto sampler, separation module 2695 HPLC system with PDA detector at wavelength 270 nm. Results: The retention time for Cobicistat and Atazanavir were 1.678 and 3.895 minute respectively. The correlation coefficient values in linearity were found to be 0.999 and concentration range 50-150 μg/ml for Cobicistat and 50-150 µg/ml for Atazanavir respectively. For accuracy The total recovery was found to be 100.63 % and 101.79 % for Cobicistat and Atazanavir. LOD and LOQ for Cobicistat 1.32 and 4.01. LOD and LOQ for Atazanavir 0.40 and 1.22. Cobicistat and Atazanavir were subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. Cobicistat and Atazanavir are more sensitive towards acidic and Thermal degradation. Conclusion: The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of of Cobicistat and Atazanavir in tablet dosage form.

Keywords: Cobicistat, Atazanavir, RP?HPLC, Simultaneous estimation


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