Review Article
Sandeep Reddy Katla, Venisetty
Abstract
A simple and sensitive stability indicating reverse phase high performance liquid chromatography method with simple UV detection was developed for the estimation of rilpivirine. The HPLC analysis was carried out on Waters ODS (C8) Column, 250 mm x 4.6 mm in isocratic mode with a mobile phase of acetonitrile-0.01M potassium dihydrogen orthophosphate (40:60 v/v). The method was validated according to ICH guidelines. The values obtained were found to be within acceptable limits. The method was found to be linear over a concentration range of 5- 30 μg/ml. The detection wavelength was selected from the UV spectra as 282 nm. The limit of detection and limit of quantitation was found to be as 0.05μg/ml and 0.15 μg/ml respectively. Forced degradation studies were performed for both the drugs. The drugs were degraded in acidic, basic and oxidative conditions. The peaks of degraded products were well resolved from the actual drug. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method. The method was successfully applied for the estimation of marketed formulation (tablet dosage form).