Development of a new HPLC method for simultaneous determination of clopidogrel and its major metabolite using a chemometric approach

Current Health Sciences Journal

Valentina Anutareplacement¹ 

关键词: Clopidogrel;    Clopidogrel carboxylic acid;    HPLC;    Design of Experiments;    degradation study;   

DOI  :  10.12865/CHSJ.41.01.02

学科分类：医学（综合）

来源: Universitatea de Medicina si Farmacie din Craiova / University of Medicine and Pharmacy

【 摘 要 】

This paper presents the development and validation of a new HPLC-UV method for simultaneous quantitative determination of clopidogrel and its hydrolysis product clopidogrel carboxylic acid (CCA) from bulk material and dosage formulations. Development of the chromatographic method is based on a design of experiments (DOE) approach. A Box-Behnken experimental design was used to build the mathematical models and to choose the significant parameters for the optimization by simultaneously taking resolution, capacity factor and peak symmetry as responses. Derringer s desirability function was used for the selection of the optimum experimental conditions in terms of mobile phase composition, column temperature and flow rate. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision, robustness and system suitability. The method was further employed for the study of clopidogrel bisulfate hyd.

【 授权许可】

Unknown