DEVELOPMENT AND VALIDATION OF AN ANALYTICAL METHOD FOR DISSOLUTION TESTING OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE IN TABLET DOSAGE FORM BY UPLC

Abstract

A simple, accurate and precise UPLC method was developed and validated for dissolution testing of Emtricitabine and Tenofovir disoproxil fumarate in tablet dosage form. The separation was achieved under optimized chromatographic condition on an Acquity UPLC HSS (50 mm X 2.1 mm, 1.7 $\mu$ m) column with mobile phase consist of 20 mM Potassium dihydrogen phosphate buffer pH 3.5: Acetonitrile with gradient elution at a flow rate of 0.640 ml/min using 30°C column oven temperature with UV detection at 262 nm. The retention time for Emtricitabine and Tenofovir disoproxil fumarate were about 0.715 and 2.239 min respectively. The linearity was found to be in the concentration range of 20.14  120.86 $\mu$ g/mL for Emtricitabine and 30.01-180.04 for Tenofovir disoproxil fumarate. The % recoveries at 20%, 100% and 120% were found to be within the limit of 98-102%. 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.