RP-HPLC Analysis of Clopidogrel Bisulphate in Pharmaceutical Dosage form: Method Development and Validation-Reference-Cited by-同舟云学术

RP-HPLC Analysis of Clopidogrel Bisulphate in Pharmaceutical Dosage form: Method Development and Validation

Published:2024-07-24 Issue: Volume: Page:3109-3114
ISSN:0974-360X
Container-title:Research Journal of Pharmacy and Technology
language:en
Short-container-title:RJPT

Author:

Puri Monika¹,Kumar Walia Yogesh²

Affiliation:

1. Research Scholar, Career-Point-University, Hamirpur (H.P.), India.

2. Professor, Department of Chemistry, Career-Point-University, Hamirpur (H.P.), India.

Abstract

Clopidogrel Bisulphate, chemicallymethyl-(2 S)-2- (2-chlorophenyl)-2- (6,7-dihydro-4 H -thieno-[3,2-c]pyridin-5-yl)-acetate;-sulfuric acid is a potent anti-platelet and anti-thrombotic drug. The present study was aimed to develop a new reliable, simple and reproducible method for the estimation of clopidogrel bisulphate in bulk and pharmaceutical dosage form. The RP-HPLC method selected for estimation and validation was performed on C18 column (250nm x 4.5mm, 5µm) by employing Waters’ HPLC model using acetonitrile and water at pH 3.00 with 0.1% (v/v), orthophosphoric acid (55:45) at flow rate of 1.0ml/min. UV detection was set at 237nm and retention time was found to be 15.7min and percentage recovery was 100.7% for COP in the concentration range 60-90µg/ml with a correlation value (R2) of 0.999 suggesting the accuracy of method selected. The developed method was validated concerning accuracy, linearity, precision, specificity, and robustness. The proposed method was found to be completely in agreement with ICH guidelines and can be used effectively in analysis of COP in bulk and pharmaceutical dosage form.

Publisher

A and V Publications

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