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 Phenomenex- Luna C18 (25 cm x 4.60 mm, particle size 5 µm) column with a mixture of 10mM phosphate buffer (pH 6.8): Acetonitrile; 40: 60 (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 2.81 and 7.42 min for emtricitabine and tenofovir disoproxil fumarate respectively and total run time was 10 min. at a flow rate of 1.0 mL/ min. The calibration curve was linear over the concentration range of 40.00 - 240.00 µg/ mL for emtricitabine and 60.00 - 360.00 µg/ mL for tenofovir disoproxil fumarate. The LOD and LOQ values were found to be 1.54 and 4.54 µg/ mL for emtricitabine and 4.60 and 13.65 µg/ mL 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.
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