Mon, 20 Nov 2017

Development and Validation of Stability Indicating Method for Simultaneous Estimation of Embtricitabine and Tenofovir

MN Trinath, BM Gurupadayya* Shiva Prasad, Shilpa Kache

Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS University, Mysore 570 015, India


ABSTRACT

A simple rapid, sensitive, selective and reproducible reversed- phase high-performance liquid chromatographic method has been developed and validated for the simultaneous estimation of embtricitabine and tenofovir in pure and Pharmaceutical dosage form. In present work a simple, sensitive and specific method (RP-HPLC assay, stability indicating RP-HPLC) has been developed for the simultaneous estimation of embtricitabine and tenofovir in pure and Pharmaceutical dosage form. A phenomenex BDS C18, column having 5 µm particle size and 150 mm x 4.6 mm in length and gradient mode, with mobile phase containing  potassium dihydrogen phosphate (pH3.0, adjusted with O-phosphoric acid) and  acetonitrile in the ratio of 96:4. The flow rate was 1.0ml/min and effluents were monitored by UV detector at 254nm. The retention times of emtricitabine and tenofovir is 3.1±0.1 & 6.1±0.1 min was recorded at 254nm. The method is linear and the correlation coefficient was found to be 0.999. The method was validated for linearity, precesion, accuracy, solution stability, ruggedness, and post degradation studies were performed. Recoveries from formulations were between 98.3 and 99.5%. The results of specificity studies indicated no interference from excipients, impurities, and degradation products under various stress conditions and assured that the peak response was due to a single component only. Hence, the present method is cost-effective, faster, and can be used for the routine analysis of these drugs in pure and formulations.

Keywords: RP-HPLC method, Embtricitabine, Tenofovir Validation and Stability studies


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