Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR DISSOLUTION OF LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE AND EFAVIRENZ IN TABLET DOSAGE FORM BY HPLC

Parth Patel*, Dr. T. Y. Pasa, Bhupat Vihol, Nimit Vasa and Shyamal Patel

ABSTRACT

A simple, accurate and precise RP-HPLC 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 a Inertsil ODS-3V C18 (100 mm X 4.6 mm, 3 μm) column with mobile phase consist of 20mM Potassium dihydrogen phosphate buffer pH 2.5: Acetonitrile with gradient elution at a flow rate of 1.0 ml/min using 35°C column oven temperature with UV detection at 260 nm. The retention time for Lamivudine, Tenofovir disoproxil fumarate and Efavirenz were about 2.839, 7.424 and 8.572 min respectively. The linearity was found to be in the concentration range of 60.2 – 361.4 μg/mL for lamivudine, 59.4 – 356.4 μg/mL for Tenofovir disoproxil fumarate and 120.5 – 722.8 μg/mL for Efavirenz. 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.

Keywords: Lamivudine, Tenofovir disoproxil fumarate, Efavirenz.