A Validated RP-HPLC Method for Estimation of Rilpivirine in Bulk and Pharmaceutical Dosage Form

A New RP-HPLC method was developed and validated for estimation of rilpivirine hydrochloride. A simple, selective, precise, accurate and robust method was developed and validated according to the ICH guidelines for the estimation of Rilpivirine hydrochloride in bulk and tablet dosage form. The method developed is more simple, robust and accurate than the existing methods. The estimation was carried out on C18 column (150 x 4.6 mm, 5μ) using Phosphate Buffer (pH 6.0): Methanol: Acetonitrile in the ration of 40:5:55 (v/v) as mobile phase. The flow rate was 1.2 ml/min and the effluent was monitored by PDA detector at 280 nm. The retention time was 4.74 and Linearity was observed in the concentration range of 25-150 μg mL-1 with regression equation y = 34443x - 8259.4 (R<SUP>²</SUP> = 0.9997). The mean % recovery obtained is 98.6%. The percentage recovery was in good agreement with the labeled amount in the pharmaceutical formulations and the method is simple, precise, accurate and robust for the determination of rilpivirine hydrochloride in pharmaceutical formulations.