DEVELOPMENT AND VALIDATION OF UPLC METHOD FOR ESTIMATION OF % RELEASE OF SOME ANTI-HIV DRUGS IN FIXED DOSE COMBINATIONAbstract
A simple, accurate and precise UPLC method was developed and validated for dissolution testing of Lamivudine, Tenofovir disoproxil fumarate and Efavirenz in tablet dosage form. The separation was achieved under optimized chromatographic condition on an Acquity UPLC BEH (50 mm × 2.1 mm, 1.7 μm) column with mobile phase consist of 20 mM potassium dihydrogen phosphate buffer pH 2.5: acetonitrile with gradient elution at a flow rate of 0.37 mL/min using 35 °C column oven temperature with UV detection at 260 nm. The method was validated as per ICH and USP guideline and the values were found to be within the limits. So, the proposed method was found to be simple, linear, accurate, precise, robust and specific.