Development and validation of stability indicating RP-HPLC method for the estimation of Cobicistat in bulk and tablet dosage form

Abstract

A validated new stability indicating RP-HPLC method for the quantitative estimation of Cobicistat in bulk and
Tablet dosage form was developed as per ICH guidelines. The analyte was injected into Symmetry (C18) Column,
250 mm x 4.6 mm i.d. and 5µm particle size, maintained at ambient temperature and effluent was monitored at 247
nm. The mobile phase was consisted of HPLC Grade Methanol and HPLC Grade Water in the ratio of 35:35 v/v.
The flow rate was maintained at 1.0 mL/min. The calibration curve for Cobicistat was linear from 0 to 70μg/mL
(r2=0.999). The inter-day and intra-day precision was found to be within limits. The Limit of detection (LOQ) and
Limit of quantification (LOQ) for Cobicistat was found to be 0.09 and 0.27μg/mL respectively. The average %
recovery for Cobicistat was 98-102% and repeatability was found to be satisfactory. This RP-HPLC method is
suitable for determining the concentration of Cobicistat in bulk and Tablet dosage form and it can applied for
routine analysis for estimation of the Cobicistat.