Development and validation of a methodology for HPLC analysis of clopidogrel-Reference-Cited by-同舟云学术

Development and validation of a methodology for HPLC analysis of clopidogrel

Published:2022-12-23 Issue:4 Volume:22 Page:33-39
ISSN:2410-3764
Container-title:Aspirantskiy Vestnik Povolzhiya
language:
Short-container-title:Aspirantskiy Vestnik Povolzhiya

Author:

Anosova Ludmila S.^ORCID,Remezova Irina P.^ORCID,Agafonov Alexey M.^ORCID

Abstract

Aim to develop a methodology for the chemical and toxicological analysis of clopidogrel using HPLC. Material and methods. The study was performed on Clopidogrel bisulfate substance-powder, manufacturer: PJSC "Farmak", Ukraine, corresponding to the European Pharmacopoeia with an active substance content of 99.31% (LM2504208 series). For the chromatographic analysis we used a micro-column liquid chromatograph "Milichrome A-02" (CJSC "Econova", Russia). The analysis was done according to the unified HPLC technique developed by G.I. Baram. Results. The highest spectral ratio by HPLC was observed at 280 nm / 210 nm (maximum clopidogrel peak area R = 1.0787). The calibration curve for the HPLC method was described by the equation: у = 0.0005912х 0.001385 (r = 0.9998; S02 = 25.2910-7); linearity within 1400 mcg/ml, which corresponded to the content of clopidogrel in the sample from 2 ng to 800 ng, respectively. Based on the values of the calibration curve, the LOD and LOQ were calculated: 2,334 mcg/ml and 7,074 mcg/ml, respectively. Conclusion. A technique for the quantitative determination of clopidogrel by HPLC has been developed that allows for determining the substance in a mixture. The methodology was validated according to the following criteria: specificity, limit of detection, limit of quantitative determination, linearity, correctness and precision.

Publisher

Samara State Medical University

Link

https://aspvestnik.ru/2410-3764/article/viewFile/111061/pdf

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