Development of an RP-HPLC method for multicomponent tablet formulation containing Cobicistat and Darunavir

Abstract

A reverse phase-high performance liquid chromatographic method for simultaneous analysis of Cobicistat (COB) and Darunavir (DAR) 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 60:10:30 of buffer (1 ml of Orthophosphoric acid in 1000 ml of water), methanol and acetonitrile respectively as mobile phase, at a flow rate of 1 ml per minute. UV detection at 210 nm. By the proposed method, COB and DAR were eluted with retention times of 4.88 and 4.35 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 of 19.55 to 28.60 mcg/ml for COB and 103 to 149 mcg/ml for DAR. Limit of detection was 1.98, and 2.46 mcg/ml and Limit of quantitation were 6.01 and 7.38 mcg/ml for COB and DAR respectively. Robustness was studied by determining the effect of small deliberate variations in the chromatographic conditions. The conditions studied were flow rate was altered by ±0.5 ml/minute and the detection wavelength was altered by ± 2 nm.