Stability Indicating Rp-Hplc Method Development and Validation for Simultaneous Estimation of Rivaroxaban and Clopidogrel Bisulphate in Pharmaceutical Dosage Form
A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of Rivaroxaban and Clopidogrel, using a C18 (25cm x 0.46 cm) Hypersil BDS column and a mobile phase composed of buffer (pH 4.5): methanol (70:30). The detection was carried out at wavelength 214 nm. The retention times of Rivaroxaban and Clopidogrel were found to be 3.300 min and 4.740min, respectively. Linearity was established for Rivaroxaban and Clopidogrel in the range of 2-6μg/ml and 7.5-22.5μg/ml, respectively. The percentage recoveries of Rivaroxaban and Clopidogrel were found to be 100.09% and 99.79%, respectively. Both the drugs were subjected to acid, alkali, oxidation, thermal and photolytic UV degradation. The degradation study shows that both drugs are susceptible in all parameter. Clopidogrel is more susceptible for photo and thermal degradation. It shows less degradation in basic environment as compare to all others. Clopidogrel shows average thirty percent degradation in UV light which is highest degradation as compare to other. Rivaroxaban is more susceptible for thermal and oxidative degradation. It shows less degradation in basic environment as compare to all others. Both drug’s degradation products were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for simultaneous quantitative analysis of Rivaroxaban and Clopidogrel in bulk drugs and formulations. The proposed method was found to be accurate, reproducible, and consistent. The method was validated in compliance with ICH guidelines.
