A NOVEL STABILITY INDICATING RP-HPLC METHODDEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF CLOPIDOGREL IN BULK ANDITS DOSAGE FORMS

Abstract

A Simple, rapid and sensitive stability indicating Reverse Phase High Performance Liquid Chromatographic method was developed for the estimation of Clopidogrel (CLG) in presence of its oxidative, acid, alkali and thermal degradation and neutrality of drug. The method was validated as per International Conference on Harmonization (ICH) guidelines. The mobile phase used in this study is a mixture of Acetonitrile: OPA - Ortho phosphoric acid buffer (50:50v/v). Stationary phase was Discovery AltimaC18 (150mm x 4.6 mm, 5µm) reverse phase column at 30oC ambient temperature. The analysis was performed with run time of 10.0 minutes at a flow rate of 1.00ml/min. The CLG was monitored at 240nm with UV detection and CLG was eluted at 2.7min. The method was linear (0.9998) at concentration ranging from 25to150µg/ml, precise (intra-day relative standard deviation (RSD) and inter-day RSD values < 1.0%), accurate (mean recovery = 99.41%), specific and robust. Detection and quantification limits were 18.7µg/ml and 112.5µg/ml, estimated from linearity by regression analysis. The results showed that the proposed method was suitable for rapid determination of clopidogrel in bulk dosage forms.