Development and Validation of Stability Indicating Related Substances Method for Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate (DLT) Tablets using High Performance Liquid Chromatography

Development and Validation of Stability Indicating Related Substances Method for Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate (DLT) Tablets using High Performance Liquid Chromatography Saravanan. R Department of Chemistry, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai, India. Somanathan. T Department of Chemistry, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai, India. Gavaskar. D Department of Chemistry, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai, India. Sriraman. V Department of Chemistry, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai, India. Tamilvanan. M Department of Chemistry, VMKV Engineering College, Vinayaka Mission’s Research Foundation, Salem, Tamilnadu, India.

A novel, accurate, specific, linear, precise and robust RP-HPLC method (stability indicating) has been developed and validated for the related substances (impurities) analysis of Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate in tablet formulation. This research paper presents the developed method and the outcome of validation challenges. The RP-HPLC method was developed on a 250 x 4.6 mm, 5 µm, C18 column, with a gradient mode using combination of phosphate buffer and phosphoric acid in methanol and water as mobile phase, the detection was performed at 265nm and 235nm. The method was subjected to validation challenges of specificity, precision, linearity, accuracy, robustness and is demonstrated to be suitable for testing of stability samples.
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