DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DARUNAVIR AND COBICISTAT IN PHARMACEUTICAL DOSAGE FORM

G. Sai Kiranmaie, P. Nagaraju*, V. Mounika and G. Indira Priyadarshini

ABSTRACT

A simple stability indicating high performance liquid chromatographic method has been developed for the simultaneous determination of Darunavir in combination with Cobicistat using reverse phase Inertsil ODS C18 (4.6 x 150mm, 5m) with UV detection at 242 nm. The mobile phase consisting of 0.1% TEA: Methanol in a ratio of (30:70, v/v) and at a flow rate of 1.2 mL/min. The method was linear over the concentration 40 -200 μg/ml for Darunavir and 7.5-37.5 μg/ml for Cobicistat. The recoveries of active pharmaceutical ingredient (API) Darunavir and Cobicistat were found to be in the range of 98.59 -99.68% and 99.87 - 101.67% respectively. The method was validated and was successfully employed for the routine quantitative analysis of pharmaceutical formulations containing amlodipine besylate and metoprolol succinate in combined tablet dosage form.

Keywords: Darunavir, Cobicistat, HPLC, Validation.