A validated RP - HPLC method for simulataneous estimation of Lamivudine and Tenofovir disoproxil fumarate in pure and in tablet dosage form

Abstract

A simple, rapid reverse - phase high performance liquid chromatographic method has been developed
and validated for the simultaneous estimation of lamivudine and tenofovir disoproxil fumarate in pure
and in tablet dosage form. The estimation was carried out on a Phenomenax Luna C18 (150 mm x 4.6
mm i.d., particle size 5µm) column with a mixture of acetonitrile: methanol: water in the ratio of
30:50:20 (v/v) as mobile phase. UV detection was performed at 258 nm. The method was validated for
linearity, accuracy, precision, specificity and sensitivity as per ICH norms. The developed and
validated method was successfully used for the quantitative analysis of commercially available dosage
form. The retention time was 3.27 and 4.15 min. for lamivudine and tenofovir disoproxil fumarate,
respectively. The flow rate was 1.0 mL min-1. The calibration curve was linear over the concentration
range of 2 –12 µg mL-1 for both lamivudine and tenofovir disoproxil fumarate. The LOD and LOQ
values were found to be 0.0099 and 0.0299 g mL-1 for lamivudine and 0.0328 and 0.0994 g mL-1 for
tenofovir disoproxil fumarate, respectively. The high percentage of recovery and low percentage
coefficient of variance confirm the suitability of the method for the simultaneous estimation of
lamivudine and tenofovir disoproxil fumarate in pure and in tablet dosage form.