Method Development and Validation of Clopidogrel Bisulphate by Reverse Phase-HPLC in Bulk and Pharmaceutical Dosage Forms

Abstract

A new, simple  sensitive,  rapid, accurate  and precise  RP-HPLC  method  was developed  for the estimation  of Clopidogrel  bisulphate  in bulk  drug and pharmaceutical  formulation.  Clopidogrel  bisulphate  was chromatographed  on a reverse phase C18column (150 mm x 4.5 mm, i.d 5μm) in a mobile phase consisting of acetonitrile and phosphate buffer (pH: 3.0) in the ratio of 60:40 % v/v. The mobile phase was pumped at a flow rate of 1 ml/min with detection at 224 nm. The detector response was linear in the concentration  of 50-150 μg/ml. The limit of detection and limit of quantitation  was found to be 1.3 and 4.2 µg/ml, respectively.  The intra and inter day variation  was found to be less than 2%. The mean recovery  of the drug from the solution  was 99.79%.  The proposed  method is simple, fast, accurate,  precise and reproducible  hence, it can be applied  for routine quality control analysis of Clopidogrel bisulphate in bulk drug and pharmaceutical  formulation.