Analytical Method Development and Validation of Stability Indicating assay method of analysis for Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate tablets using High Performance Liquid Chromatography

• Published in: Research journal of pharmacy and technology 2021-05, Vol.14 (5), p.2434-2439
• Main Authors: R, Saravanan, T, Somanathan, D, Gavaskar, M, Tamilvanan
• Format: Article
• Language: English
• Subjects: Antiretroviral drugs; Chromatography; Drug dosages; Hepatitis B; HIV; Human immunodeficiency virus; Infections; Infectious diseases; Ions; Methods; Molecular weight; Retention
• ISSN: 0974-3618; 0974-360X; 0974-306X
• DOI: 10.52711/0974-360X.2021.00428

A novel, economic, simple, precise and time-efficient reverse-phase high performance liquid chromatographic (RPHPLC) method has been established for the simultaneous assay determination of Dolutegravir, Lamivudine and Tenofovir Disoproxil fumarate in tablet formulation. This research paper presents the detailed method development strategy and the outcome of validation challenges. The RPHPLC method was developed using a 150 x 4.6mm, 5µm C18 column, with a gradient mode using 0.1% (v/v) trifluoroacetic acid buffer and methanol, the detection was performed at 260nm. The method was validated for specificity, precision, linearity, accuracy, robustness and can be used in quality control during manufacture and for assessment of the stability samples of Dolutegravir/Lamivudine/Tenofovir Disoproxil fumarate tablets. Total elution time was about 5 min and equilibration time of about 2 min which allows analysis of more than 100 samples per day. The method reported in this study is compatible to mass spectrometry and is thus extremely useful for stability studies.