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.
Key words: Clopidorgel, RP-HPLC, Forced degradation, Validation, Dosage forms.
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