RP-HPLC method development and validation of Rilpivirine

Abstract

A simple, accurate, rapid, and stability-indicating RP-HPLC method for a Rilpivirine has been developed and subsequently validated in commercial tablets. The proposed HPLC method utilizes Develosil ODS HG-5 RP C18, 5µm, 15cmx4.6mm and mobile phase consisting of ACN : Acetate buffer (pH=4.0) = 65:35 (v/v) at a flow rate of 1.0 ml/min. Quantitation was achieved with UV detection at 260nm. The method was validated in terms of accuracy, precision, linearity, limits of detection, limits of quantitation, and robustness. This optimized method has been successively applied  to  pharmaceutical formulation and  no  interference from  the  tablet  excipients  was  found. Rilpivirine drug products were subjected to acid, base, neutral hydrolysis, oxidation, dry heat, and photolytic stress conditions and the stressed samples were analyzed by the proposed method. As the proposed RP-HPLC method could effectively separate the drugs from its degradation products, it can be employed as stability-indicating method for the determination of instability of these drugs in bulk and pharmaceutical dosage form.