Abstract

DEVELOPMENT AND VALIDATION OF ABSORPTION RATIO METHOD FOR SIMULTANEOUS ESTIMATION OF ATORVASTATIN AND CLOPIDOGREL IN FORMULATION AND BULK

Dhananjay P. Chaudhari*, Prof. Sachin S. Rane, Prof. Mahesh S. Nemade, Prof. (Dr.) Rajesh Y. Chaudhari and Prof. (Dr.) Vijay R. Patil

Abstract

A simple, robust, precise, UV spectroscopic method has been developed for the simultaneous estimation of Atorvastatin and Clopidogrel in bulk and tablet dosage forms. In this paper the estimation of those drugs was carried out by absorbance ratio method. This method is based on measurement of absorption at 242nm and 232nm i.e, λmax of Atorvastatin and Clopidogrel respectively. The linearity observed for Atorvastatin is in the range of 5-25 μg/ml and for Clopidogrel is in the range of 15-75 μg/ml. The accuracy of methods was assessed by recovery studies and was found to be within the range of 99.68%-99.75% for both Atorvastatin and Clopidogrel. The developed methods were validated with respect to linearity, accuracy (recovery), and precision. The method can be employed for estimation of pharmaceutical formulations with no interference from any excipients and diluents. The results were validated as per ICH guidelines.

Keywords: Atorvastatin, Clopidogrel, Absorbance Ratio Method, ICH, Validation etc.