A NOVEL STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF TENOFOVIR DISOPROXIL FUMARATE AND EMTRICITABINE IN BULK AND PHARMACEUTICAL FORMULATIONS

The prime aim and object of present investigation is to develop and validate a novel, precise, accurate, specific, rapid and economic stability- indicating isocratic reverse phase liquid chromatography method for the quantitative simultaneous estimation of Tenofovir disoproxil fumarate and Emtricitabine in bulk and marketed formulations. Estimation of drugs in this combination was achieved with a C18 column [Agilent TC-C18 (2) column. 5mm, 4.6´250 mm]kept at ambient temperature, using mobile phase of composition Methanol and phosphate buffer (30:70 v/v, pH 4).The flow rate was 1.0 ml/min and the effluents were monitored at 261 nm, using variable wavelength UV detector. The retention time of Tenofovir disoproxil fumarate and Emtricitabine were 2.81min and 4.72min respectively. Validation of the method was done according to the ICH guidelines for different analytical parameters. The method was found to be linear over a range of 40-80mg/ml for Tenofovir disoproxil fumarate and Emtricitabine. The established method proved as reproducible one with a %RSD value of less than 2 and having the robustness and accuracy within the specified limits. Assay of marketed formulation was determined and find with 97.58% and 97.88% for Tenofovir disoproxil fumarate and Emtricitabine respectively. The stressed samples were analyzed and this proposed method was found to be specific and stability indicating as no interfering peaks of degradation compounds and excipients were noticed. Successfully employed in the estimation of commercial formulations. This liquid chromatographic method can be applied for the qualitative and quantitative determination of selected drugs by the modern chemist.