METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF EMTRICITABINE, RILPIVIRINE AND TENOFOVIRALAFENAMIDE IN BULK AND FORMULATION BY RP- HPLC METHOD

Abstract

This study was carried out to create and verify a technique for the simultaneous estimate of Rilpivirine, Tenofovir, and Emtricitabine in bulk and pharmaceutical dose form, in accordance with ICH recommendations. The suggested technique uses a mobile phase of 0.1% Trifluoroacetic acid in acetonitrile (30:70%, v/v) at a flow rate of 1.0 ml/min. This study was conducted at 265 nm on an Agilent Zorbax Bonus-RP Column (250 x 4.6 mm, 5). When this technique was validated in accordance with ICH Q2(R1) recommendations, the limits of detection (LOD) and limits of quantitation (LOQ) for rilpivirine (4.99 g/ml), tenofovir (13.36 g/ml), and emtricitabine (1.16 g/ml), respectively, were found to be adequate. It was also determined that the technique was reliable, precise, and accurate. All three concentration ranges tested (Rilpivirine 20–30 g/ml, Tenofovir 240–360 g/ml, and Emtricitabine 160–240 g/ml) were linear when using the Method. All three medications averaged between 98% and 101 % in terms of successful recoveries. The suggested approach for simultaneous estimation of Rilpivirine, Tenofovir, and Emtricitabine in bulk and pharmaceutical dose form is simple and cost-effective.