DEVELOPMENT OF STABILITY INDICATING RP-HPLC METHOD FOR MULTICOMPONENT TABLET FORMULATION CONTAINING ATAZANAVIR AND COBICISTAT

Abstract

A reverse phase-high performance liquid chromatographic method for simultaneous analysis of Atazanavir (ATA) and Cobicistat (COB) in a tablet dosage form has been developed and validated. The method was performed with Durashell C 18 column (250 X 4.6 mm) 5-micron particle column with 30:20:50 of water, methanol and acetonitrile respectively as mobile phase, pH adjusted to 5.5 with triethylamine, at a flow rate of 1 ml per minute. UV detection at 272 nm. By the proposed method, ATA and COB were eluted with retention times of 2.3 and 7.7 minutes respectively. The method was validated as per the ICH guidelines. The method was simple, rapid. specific, accurate, precise, reliable and reproducible. Calibration curve plots were linear over the concentration ranges of38 to 58 mcg/ml for ATA and 19 to 29 mcg/ml for COB. Limit of detection were 3.3 and 1.41 mcg/ml and Limit of quantitation were 10.0 and 4.28 mcg/ml for COB and ATA respectively. The forced degradation study using acid, base, oxidation with hydrogen peroxide, elevated temperature and photolytic conditions revealed the stability of solution for first and third day.