STABILITY-INDICATING RP-UPLC METHOD FOR SIMULTANEOUS DETERMINATION OF DOLUTEGRAVIR AND RILPIVIRINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

摘要

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 x 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 in isocratic mode at flow rate of 1 mL/min and detection wavelength 260 nm. The retention times of dolutegravir and rilpivirine were found to be 1.25 min, and 1.69 min with linearity in the concentration ranges from 12.5 - 75.0 μg/mL and 6.25 - 37.5 μig/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 2.0 at all the levels, indicating satisfactory accuracy and precisiom. The robustness was found to meet the acceptance criteria. The stress study against qualified working standards of dolutegravir and rilpivirine indicated that the developed UPLC method was stability- indicating, conducted as per ICH requirements.