Development and Validation of HPLC Method for Simultaneous Estimation of Emtricitabine, Rilpivirine and Tenofovir Disoproxil Fumarate Tablet Dosage form
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2018, Vol 6, Issue 1
Abstract
This study describes the development and validation of high performance liquid chromatographic (HPLC) method for the simultaneous estimation of Emtricitabine (EMT), Rilpivirine (RPV) and Tenofovir disoproxil fumarate (TFV) in tablet dosage form. Chromatographic separation of these drugs was performed on INERTSIL column, C18 (150x4.6 ID) 5µm as the stationary phase using solvent system consisted of Phosphate buffer : Acetonitrile 40:60. The method was validated according to the International Conference of Harmonization (ICH) guidelines. The calibration curves were linear over the (r2 -0.995) concentrations range from 24-56 µg /ml for Emtricitabine, 3-7 µg /ml for Rilpivirine and 30-70 µg /ml for Tenofovir disoproxil fumarate. The method showed accuracy of 100.19%, 101.30% and 99.70% and percentage assay of 100.04%, 99.74% and 102.14% for Emtricitabine, Rilpivirine and Tenofovir disoproxil fumarate, respectively. Percentage relative standard deviation (<2%) was found for both precision and robustness study showing that the proposed method was precise, specificity, robust and stable in accordance with ICH guidelines.
Authors and Affiliations
D. Karunakranth, Anil Kumar Midha,R. Sridhar Babu and DV. Kishore
Keywords
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