METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ROPINIROLE HCL IN TABLETS BY RP-HPLC

Abstract

A simple and precise and accurate RP - High-performance liquid chromatography (Reverse Phase - HPLC) method has been developed for the estimation of Ropinirole in tablet formulations. The separation was achieved on a C18(250 x 4.6 mm) 5 - micron Hypersil BDS using a mobile phase consisting of a degassed mixture of 0.05 M glacial acetic acid (2.85 mL of glacial acetic acid in 1000 mL of water) and acetonitrile (50:50) with a flow rate of 1.0 mL/min. The mobile phase showed the most favorable chromatographic parameter for analysis. The detection of the constituent was done using UV detector at 250 nm. The retention time of ropinirole was found to be 3.987 minutes. The method was validated for system suitability, precision, accuracy, linearity, robustness. The linear range for ropinirole was 4 12 g / ml. The method is validated for accuracy, precision, linearity, specificity and robustness in accordance with ICH guidelines and revealed that the method established specific, accurate, rapid, precise, reliable and reproducible for the method has been successfully used to analyze commercial solid dosage forms which are locally available 0.25 mg ropinirole tablets and its percentage recovery was found to be 99.82%.