NEW ANALYTICAL METHOD VALIDATION REPORT AND FORCED DEGRADATION STUDIES FOR ASSAY OF ELVITEGRAVIR, TENOFOVIR, EMTRICITABINE AND COBICISTAT BY RP-UPLC

The main aim of the present work is to develop and validate a simple, specific, efficient, accurate, and precise stability-indicating rapid reversed phase ultra performance liquid chromatographic method is developed for the simultaneous determination of Elvitegravir, Tenofovir, Emtricitabine, and Cobicistat in its bulk and pharmaceutical combined dosage form with forced degradation studies. The four compounds is separated on a reversed phase Endoversil C18(50 x 2.1mm,1.8µm particle size) column, waters ACQUITY UPLC system with PDA detector and a mobile phase composed of 0.1% OPA: acetonitrile (70:30, v/v), pH 3.0 adjusted with ophosphoric acid. The flow rate is set to 0.3ml/min with respones measured at 252nm. The retention time of Elvitegravir, Tenofovir, Emtricitabine, and Cobicistat is found to be 0.594min, 0.734m i n , 0.487min, 2.515min with resolution of 3.19, 10.49, 12.25 respectively. Linearity is established in the range of 75-225μg/ml for Elvitegravir, 150-450μg/m for Tenofovir, 100-300μg/m for Emtricitabine and 75-225μg/ml for Cobicistat with correlation coefficients (r20.999). The percentage recoveries is between 99.53-10.28%, 99.60-100.97%, 100.49-100.93%, 99.65-100.52%, for Elvitegravir, Tenofovir, Emtricitabine, and Cobicistat. Keywords: Elvitegravir, Tenofovir, Emtricitabine, Cobicistat, UPLC, PDA detector, Hyphenated and ICH.