A Validated RP - HPLC Method for Simulataneous Estimation of Emtricitabine and Tenofovir Disoproxil Fumarate in a Tablet Dosage Form

Abstract

A simple, rapid reversed-phase high performance liquid chromatographic method had been developed
and validated for estimation of emtricitabine and tenofovir disoproxil fumarate in tablet dosage form.
The estimation was carried out on Luna C18 (25cm x 4.60 mm, particle size 5µm) column with a
mixture of acetonitrile: potassium dihydrogen phosphate buffer (pH 3.0 ± 0.05 adjusted with
orthophosphoric acid): triethylamine in the ratio of 70:30:0.5(v/v) as mobile phase. UV detection was
performed at 260 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 1.78 and 2.27
min. for emtricitabine and tenofovir disoproxil fumarate respectively and total run time was 4 min. at a
flow rate of 1.5 mL min-1. The calibration curve was linear over the concentration range of 5-50
µg mL-1 for emtricitabine and 5-50 µg mL-1 for tenofovir disoproxil fumarate. The LOD and LOQ
values were found to be 0.015 and 0.045 µg mL-1 for emtricitabine and 0.039 and 0.117 µg 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
emtricitabine and tenofovir disoproxil fumarate in tablet dosage form