Stability Indicating Technique And Validation For Dolutegravir, Lamivudine And Tenofovir Disoproxil Fumarate By UPLC
Objective: A Modest, accurate and specificUltra Performance Liquid Chromatography stability indicating method was technologically advanced for the simultaneous estimation of Lamivudine, Tenofovir, and Dolutegravir in substance and tablet dosage form.
Methods: Anultra-performance stability indicating technique has been developed to separate all the three active ingredients. The chromatographic behaviour was Acetonitrile and 0.1% formic acid in the ratio of 80:20 as mobile phase, watersX-Bridge C8100mm x 3.0mm, 3.5µmwith a flow rate of 0.5 mL/min and monitored at 260 nm.
Results: The mean retention time of Lamivudine, Tenofovir, and Dolutegravir were found to be 0.879, 1.571 and 0.607 min respectively. Linearity of Lamivudine, Tenofovir, and Dolutegravir was found to be 20-120 µg/mL, 20-120 µg/mL and 3.4 -20.4 µg/mLrespectively.
Conclusion: The proposed method was validated in terms of Linearity, Range, Accuracy, Precision, Specificity and Robustness, stabilitystudies were carried out and the method is successfully applied to the estimation of Lamivudine, Tenofovir, and Dolutegravir in combined tablet dosage form.