QBD BASED STABILITY INDICATING RP-HPLC METHOD FOR COMBINED ANTIRETROVIRAL TABLETS

A tablet containing Dolutegravir, Lamivudine, and Tenofovir disoproxil fumarate is a combined drug of antiretroviral medication used to treat HIV/AIDS. WHO recognised this drug as the first-line treatment for adults. The primary purpose of this study is to develop and validate a simple, accurate, precise, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) method for estimating dolutegravir, Lamivudine, and Tenofovir disoproxil fumarate in bulk and tablet dosage forms by optimising chromatographic parameters using a two-level full factorial design. A 2-level full factorial design was utilised to optimise the type of column and percentage of organic phase to maximise the theoretical plates and minimise the retention time of all three drugs. The optimised strength of acetonitrile and 1% ortho phosphoric acid buffer (70:30), flow rate and the volume of injection were found to be 1ml/min and 20 µl, respectively. The retention times were found to be 3.785min, 1.529min and 3.140 min for Dolutegravir, Lamivudine and Tenofovir, respectively. The R2 values for Dolutegravir, Lamivudine and Tenofovir were found to be 0.99985, 0.99994 and 0.99923, respectively. The theoretical plate number and tailing factor for Dolutegravir, Lamivudine and Tenofovir were found to be NLT 2000 and should not be more than 2, respectively. The per cent RSD of peak areas of all measurements was found to be less than 2.0. The QBD approach was found to be an effective technique for optimising chromatographic conditions of the proposed method, which is useful for routine analysis of Dolutegravir, Lamivudine, and Tenofovir disoproxil fumarate in pharmaceutical dosage form.