Specific stability-indicating reversed-phase ultra-performance liquid chromatography (UPLC) method has been developed and validated for the simultaneous quantification of dolutegravir and rilpivirine in bulk drugs and pharmaceutical dosage forms. The optimized conditions for the developed UPLC method are SB C8 column (100 × 3 mm, 1.8 mm) maintained at 30°C with mobile phase consisting of 0.1% ortho phosphoric acid and acetonitrile in the ratio 55:45% v/v on isocratic mode at flow rate of 1 ml/min and detection wavelength 260 nm. The retention time of dolutegravir and rilpivirine was found to be 1.25 min, and 1.69 min with linearity in the concentration range from 12.5-75.0 µg/ml and 6.25-37.5 µg/ml respectively. The mean percentage recoveries of dolutegravir and rilpivirine were found to be 99.04%-99.79% and 99.20%-99.92%, respectively. The percent relative standard values were less than 2 at all the levels indicates a satisfactory accuracy and precise. Performed the robustness found to meet the acceptance criteria. The stress study against qualified working standards of dolutegravir and rilpivirine, which indicated that the developed UPLC method was stability-indicating, conducted as per ICH requirements.
