Development and Validation of Ropinirole Hydrochloride and its Related Compounds by UPLC in API and Pharmaceutical Dosage Forms

Abstract

AbstractA novel stability‐indicating gradient reverse phase ultra performance liquid chromatographic (RPUPLC) method was developed for the determination of purity of Ropinirole in presence of its impurities and forced degradation products. The method was developed using Waters Aquity BEH 100 mm, 2.1 mm, 1.7 μm C‐8 column with mobile phase containing a gradient mixture of solvent A and B. The eluted compounds were monitored at 250 nm. The run time was within 4.5 min which Ropinirole and its four impurities were well separated. Ropinirole was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Ropinirole was found to degrade significantly in oxidative and base stress conditions and stable in acid, water, hydrolytic and photolytic degradation conditions. The degradation products were well resolved from main peak and its impurities, thus proved the stability indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. This method was also suitable for the assay determination of Ropinirole in pharmaceutical dosage forms and dissolution studies.