Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF ATAZANAVIR SULFATE AND COBICISTAT IN TABLET DOSAGE FORMS

Jahnavi Bandla* and S. Ganapaty

Abstract

A stability indicating method was developed for the simultaneous estimation of Atazanavir sulfate and Cobicistat in pharmaceutical dosage form by using Reverse Phase High Performance Liquid Chromatography (RP-HPLC). The separation was done on isocratic mode with Discovery C18 (250mm x 4.6 mm, 5) column and 0.01N Potassium dihydrogen phosphate and acetonitrile (40:60%v/v) as mobile phase at a flow rate of 1.0ml/min and at room temperature. The detection was done at a wavelength of 235nm. The retention time for Atazanavir was found to be 3.15min and for Cobicistat was found to be 2.32min. A good linearity was observed in the concentration range of 75μg/mL - 450μg/mL for Atazanavir and 37.5μg/mL to 225μg/mL for Cobicistat, with a correlation coefficient of 0.999 for both the drugs. The method was validated according to the ICH guidelines. The developed method was found to be accurate, precise, specific, rugged and robust. The drug was found to be stable at forced degradation conditions and the net degradation was found to be within the limits. The developed method can be used for the quality control of Atazanavir sulfate and Cobicistat in pharmaceutical dosage form.

Keywords: Atazanavir sulfate, Cobicistat, RP-HPLC, stability indicating method, method development, validation.