Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Rosuvastatin and Clopidogrel in Pharmaceutical Dosage Form
A simple, precise, rapid, specific and accurate stability indicating reverse phase high performance liquid chromatography method was developed for simultaneous estimation of Rosuvastatin (RST) and Clopidogrel (CPG) in pharmaceutical dosage form. Chromatographic separation was performed on Zorbax-SB( C18)(150mmx4.6mm, 5μ) column, with mobile phase comprising of mixture of buffer (pH 3, adjusted with ortho phosphoric acid), and methanol in the ratio of 60:40 v/v, at the flow rate 1.2 ml/min. The detection was carried out at 254 nm. The retention times of RST and CPG were found to be 1.6 and 2.5 mins respectively with a run time of 6 mins, theoretical levels for RST and CPG were found to be 5050 and 5503 respectively, with a resolution of 5.88. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of detection and limit of quantitation, robustness and ruggedness. Linearity of RST was found in the range of 10-30 μg/mL and that for CPG was found to be 75-225 μg/mL. The correlation coefficient for RST and CPG were found to be 0.999 and 0.999 respectively. The LOD values for RST and CPG were found to be 2.61 and 2.88 μg/mL respectively. The LOQ values for RST and CPG were found to be 8.70 and 9.62 μg/mL respectively. The results of the degradation studies indicated the suitability of the method to study stability of RST and CPG under various forced degradation conditions viz. acid, base, dry heat, photolytic degradation. The developed method can be applied to the analysis of stability samples of combination dosage form of RST and CPG. This demonstrates that the developed method is simple, precise, rapid, selective, accurate and reproducible for simultaneous estimation of RST and CPG in pharmaceutical dosage form.