Estimation of lamivudine, tenofovirdisoproxil fumarate and efavirenz in bulk and pharmaceutical dosage form by RP HPLC method

The main aspiration of this research work is to assess and validate the stability indicating RP-HPLC for concurrent estimation of Lamivudine, tenofovir disoproxil fumarate and efavirenz in bulk and marketed formulation. The exploration was carried out by using Hypersil BDS column, (150×4.6mm, particle size 5µ ) and PDA detector at 258nm. The mobile phase containing Methanol:0.1% TFA Buffer: acetonitrile (30:40:30v/v) in isocratic mode pumped into a column at a flow rate 0.8mL/min. The method was validated according to ICHQ2 (R1) guidelines. The linearity was perceived in the range of 10-50 µg/mL for Lamivudine, Tenofovir disoproxil fumarate and 20-100 µg/mL for Efavirenz respectively. The method was accurate with% recovery of 100.41%, 99.69% and 99.75% for Lamivudine, Tenofovir disoproxil fumarate and Efavirenz respectively. The percentage relative standard deviation was NMT 2.0, indicating that it was precise and robust. Under stress instances, execution of forced degradation studies such as acidic (0.1N HCl), basic (0.1N NaOH), oxidative (3% H2O2), photolytic (60%RH) and thermal (80⁰C). The extent of degradation was accomplished within the acceptable limits i.e., 5-20%. The developed method was sophisticated, precise, accurate and can be utilized for the estimation of lamivudine, ten of ovirdisoproxil fumarate and efavirenz in bulk and tablet dosage form.