Abstract

A NEW STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATIONFOR THE QUANTITATIVE DETERMINATION OF EMITRICITABINE AND TENOFOVIR DISPROXIMAL FUMARATE BY RP-HPLC

B. Vinay Kumar, U. Anusha* and G. Shiny

Abstract

A novel stability indicating, precise, accurate and ecofriendly reverse phase high performance liquid chromatographic method was developed and validated for the quantitative determination of Emtricitabine and Tenofovir disproximal fumarate in pure and pharmaceutical dosage forms. Estimation of drugs in this combination was done with a C18 column Kromasil C18 column. 5m, 4.6250 mmusing mobile phase of composition Methanol and phosphate buffer (40:60 v/v, pH 4). The flow rate was 1.0 ml/min and the effluents were monitored at 261 nm. The retention time of Tenofovir disoproxil fumarate and Emtricitabine were 2.810 min and 4.727 min respectively. The linearity was found to be 40-80g/ml for Tenofovir and 40-80g/ml for Emtricitabine. The stability parameters were evaluated by injecting the stressed sample and it was proved that there was no degradants. The established method was validated according to ICH guidelines.

Keywords: Emtricitabine, Tenofovir disoproxil fumarate, RP-HPLC, Stability and Method validation.