Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION BY HPLC FOR LAMIVUDINE, TENOFOVIR AND DOLUTEGRAVIR IN TABLET DOSAGE FORM

Swati Gondaliya, Janki Patel*, Ragin Shah, Divyakant Patel and Hiren Doshi

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Abstract

For the simultaneous measurement of dolutegravir, lamivudine, and tenofovir disoproxil fumarate in tablet dosage form, a stabilityindicating HPLC method was created and verified. The goal of the study was to develop a straightforward, reliable, accurate, and repeatable procedure for regular stability and quality control tests. Using a Perkin Elmer C18 column (150 mm × 4.6 mm, 5 μm) and a gradient mobile phase made up of methanolic orthophosphoric acid solution (mobile phase B) and ammonium acetate buffer (mobile phase A), chromatographic separation was accomplished. With no interference from diluent, placebo, or known contaminants, the technique showed specificity and successfully separated the analyte peaks from excipients and degradation products. The method's capacity to indicate stability was confirmed by forced degradation studies conducted under acidic, basic, oxidative, thermal, and photolytic conditions. These investigations revealed considerable degradation under alkaline and oxidative stress. After evaluation, it was determined that the method validation parameters—specificity, linearity (50–150%), precision, accuracy, robustness, solution stability, and filter compatibility—met ICH Q2 (R2) requirements. The approved technique can be used for regular stability testing and quality control of fixed-dose combination tablets that contain tenofovir, lamivudine, and dolutegravir.

Keywords: Lamivudine, Tenofovir, Dolutegravir, HPLC method, Forced degradation study.