New validated rp-hplc method for simultaneous estimation of lamivudine and tenofovir disproxil fumarate in tablets

Abstract

A simple, specific and precise reverse phase high performance liquid chromatographic method was developed and validated for simultaneous estimation of Lamivudine and Tenofovir disproxil fumarate in tablets. Quantification was achieved by using a reverse-phase C18 column (Inertsil ODS 3V, 250 mm x 4.6 mm; 5) at 31 ^o C. The mobile phase consisted of a mixture of phosphate buffer and acetonitrile in the ratio of 55:45 v/v at a flow rate of 1.2 mL/min. The retention times of Lamivudine and Tenofovir disproxil fumarate were found to be 2.430 min and 4.550 min respectively. The developed method was validated as per ICH Guidelines for linearity, accuracy, precision, detection limit, quantification limit, ruggedness, robustness, specificity and system suitability. The percentage recoveries for both of the drugs from their tablets were found to be 98.48 % and 98.64 % respectively. The method may successfully be employed for the simultaneous determination of Lamivudine and Tenofovir disproxil fumarate in pharmaceutical tablet dosage forms.