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


Rajesh Sharma and Pooja Gupta

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Keywords

Emtricitabine; Tenofovir disoproxil fumarate; RP-HPLC; Validation

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.