Abstract

Development and validation of stability indicating RP-HPLC method for the determination of clopidogrel bisulphate in bulk and its dosage forms

Author(s): V Sivarama Krishna, D Ravi Kumar, K Balamuralikrishna and C Rambabu*

A rapid and sensitive stability indicating Reverse Phase High Performance Liquid Chromatographic [RP-HPLC] method was developed for the estimation of Clopidogrel bisulphate [CGB] in presence of its oxidative, acid, alkaline and thermal degradation products. The method was validated as per International Conference on Harmonization [ICH] guidelines. The mobile phase used in this study is a mixture of acetonitrile and tetrabutyl ammonium hydrogen sulphate buffer. Stationary phase was waters symmetry C8 reverse phase column (150×3.9mm, 5μm) dimensions at ambient temperature. The analysis was performed with run time of 18.0 minutes at a flow rate of 1.00ml/min. The CGB was monitored at 225nm with UV detection and CGB was eluted at 4.59min. The method was linear (r2 =0.999) at concentration ranging from 100 to 600μg/ml, precise (intra-day relative standard deviation [RSD] and inter-day RSD values < 1.0%), accurate (mean recovery = 99.5%), specific and robust. Detection and quantification limits were 27.0μg/ml and 92.0μg/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.

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