Saravanan. R, Somanathan. T, Gavaskar D, Tamilvanan M
Saravanan. R1, Somanathan. T1*, Gavaskar D1, Tamilvanan M2
1Department of Chemistry, Vel’s Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai, India
2Department of Chemistry, K.S.R College of Engineering, Tiruchengode, Namakkal, India
Volume - 14,
Issue - 5,
Year - 2021
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.
Cite this article:
Saravanan. R, Somanathan. T, Gavaskar D, Tamilvanan M. Analytical Method Development and Validation of Stability Indicating assay method of analysis for Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate tablets using High Performance Liquid Chromatography Research Journal of Pharmacy and Technology. 2021; 14(5):2434-9. doi: 10.52711/0974-360X.2021.00428
Saravanan. R, Somanathan. T, Gavaskar D, Tamilvanan M. Analytical Method Development and Validation of Stability Indicating assay method of analysis for Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate tablets using High Performance Liquid Chromatography Research Journal of Pharmacy and Technology. 2021; 14(5):2434-9. doi: 10.52711/0974-360X.2021.00428 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-5-12
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