SIMULATANEOUS ESTIMATION OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE IN A TABLET DOSAGE FORM BY RP-HPLC METHOD

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 C 18 (25cm x 4.60 mm, particle size 5µm) column with a mixture of acetonitrile: phosphate buffer (pH 6.8) in the ratio of 60:40 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 2.883 and 3.89 min. for emtricitabine and tenofovir disoproxil fumarate respectively and total run time was 8 min. at a flow rate of 1.0mL min-1. The calibration curve was linear over the concentration range of 4 - 24 µgmL-1 for emtricitabine and 6-36 µg mL-1 for tenofovir disoproxil fumarate. The LOD and LOQ values were found to be 0.05318 and 0.16115 µg mL-1 for emtricitabine and 0.06782 and 0.2553 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.