Development and Validation of RP-HPLC Method for the Estimation of Dolutegravir and Rilpivirine in Bulk and its Tablet Dosage form

Abstract

S T A C T An accurate and precise method was developed and validated for the simultaneous estimation of the Dolutegravir and Rilpivirine in Tablet dosage form. Chromatogram was run using Agilent C 18 column (4.6x150mm, 5 m m) with mobile phase containing KH 2 PO 4 buffer of pH 3.5 and Acetonitrile in the ratio of 45:55 v/v was pumped through column at a flow rate of 1mL/min. Temperature was maintained at 30 ◦ C. Selected wavelength was 240.0 nm. Retention time of Dolutegravir and Rilpivirine was found to be 2.239 min and 2.899 min respectively. %RSD of the Dolutegravir and Rilpivirine for system precision was found to be 0.9 and 0.6 respectively. Accuracy was performed in triplicate and the % Recovery was obtained as 99.33% and 100.5% for Dolutegravir and Rilpivirine respectively. LOD, LOQ values for Dolutegravir was 0.2 m g/mL, 0.6 m g/mL and for Rilpivirine was 0.02, 0.06 m g/mL respectively. So, the method developed was simple,accurateandreproduciblecanbeadoptedinregularQualitycontroltestinpharmaceuticalIndustry.