A Novel UPLC-PDA Stability Indicating Method Development and Validation for the Simultaneous Estimation of Lamivudine and Dolutegravir in Bulk and Its Tablets

Abstract

Aim: To develop a stability indicating Rp-UPLC method for the simultaneous determination of Lamivudine, Dolutegravir and their degradants in tablets. Methodology: The chromatographic separation was performed on BEH Shield RP18 (2.1 mmX100 mmX1.7 mm) using a isocratic mobile phase Potassium dihydrogen orthophosphate pH 3 adjusted with orthophosphoric acid: methanol (30:70,% v/v) at a flow rate of 0.5ml/min. Column was maintained at room temperature and eluents are monitored at 258 nm. Results: Retention times of the analytes were found to be at 0.81 and 2.78 mins for Lamivudine and Dolutegravir respectively. The calibration of peak area versus concentration, which was linear from 105 to 315 µg/ml for Lamivudine and 17.5 to 52.5 µg/ml for Dolutegravir, had regression coefficient (r2) greater than 0.999. The method had the requisite accuracy, precision and robustness for simultaneous determination of Lamivudine and Dolutegravir in tablets. Conclusion: The proposed method is simple, economical, accurate, precise and can be successfully employed in routine quality control for the simultaneous analysis of Lamivudine and Dolutegravir in pharmaceutical formulations.