International Journal of Drug Delivery Technology
Volume 14, Issue 1

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

Gampa Nagamalleswari1, MS Uma Shankar2*

1Department of Pharmaceutical Analysis, SRM College of Pharmacy, SRMIST, Kattankulathur, Tamil Nadu, India.

2Department of Pharmaceutics, SRM College of Pharmacy, SRMIST, Kattankulathur, Tamil Nadu, India. 

Received: 08th December, 2023; Revised: 09th January, 2024; Accepted: 18th February, 2024; Available Online: 25th March, 2024

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.

Keywords: Lamivudine, Tenofovir, Dolutegravir, UPLC, Stability indicating method, Validation. International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.1.02

How to cite this article: Nagamalleswari G, Shankar MSU. Stability Indicating Technique and Validation for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate by UPLC. International Journal of Drug Delivery Technology. 2024;14(1):9-13.

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