Stability Indicating Technique and Validation for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate by UPLC

Abstract

Objective: To simultaneously estimate lamivudine, tenofovir, and dolutegravir in substance and tablet dosage form,” a technologically sophisticated approach was developed for ultra-performance liquid chromatography (UPLC) stability indicating that is modest, accurate, and specific. Methods: We were able to isolate each of the three active components using a state-of-the-art stability-indicating approach. Waters X-Bridge C8 column, 100 x 3.0 mm, 3.5 µm, 0.5 mL/min flow rate, and monitoring at 260 nm were used for the chromatographic behavior, which was shown by a mobile phase consisting of acetonitrile and 0.1% formic acid in an 80:20 ratio. Results: A mean retention time of 0.879 minutes was recorded for lamivudine, 1.571 minutes for tenofovir, and 0.607 minutes for dolutegravir. “The degrees of linearity for lamivudine, tenofovir, and dolutegravir were determined to be 20 to 120 µg/mL, 20 to 120 µg/mL, and 3.4 to 20.4 µg/mL, respectively. Conclusion: Combination tablet dosage forms of lamivudine, tenofovir, and dolutegravir were accurately and reliably estimated using the suggested technique, which underwent validation in terms of linearity, range, accuracy, precision, specificity, and robustness. Stability tests were also conducted.