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

A simple, rapid reverse - phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of emtricitabine 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 2.77 and 3.49 min. for emtricitabine and tenofovir disoproxil fumarate, respectively. The flow rate was 0.6 mL/ min. The calibration curve was linear over the concentration range of 2 –12 μg mL-1 for emtricitabine and 1-6 μg/ mL for tenofovir disoproxil fumarate. The LOD and LOQ values were found to be 0.03003 and 0.091015 mg/ mL for emtricitabine and 1.4270 and 4.3243mg/ 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 pure and in tablet dosage form.

Author(s): Anandakumar Karunakaran, Kannan Kamarajan and Vetrichelvan Thangarasu

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