Development and validation of high-throughput liquid chromatography-tandem mass spectrometric method for simultaneous quantification of clopidogrel and its metabolite in human plasma.

Autor: Reddy S R; Clinical Research and Biosciences (I) Pvt. Ltd., Hyderabad, Andhra Pradesh, India. raghu_nathseelam@yahoo.co.in, Rao Divi K, Chandiran IS, Jayaveera KN, Naidu YK, Reddy MP
Jazyk: angličtina
Zdroj: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences [J Chromatogr B Analyt Technol Biomed Life Sci] 2010 Feb 01; Vol. 878 (3-4), pp. 502-8. Date of Electronic Publication: 2010 Jan 04.
DOI: 10.1016/j.jchromb.2009.12.026
Abstrakt: A simple, sensitive and reliable method is described for simultaneous quantification of Clopidogrel and its metabolite in human plasma by using HTLC-MS/MS. The analytical procedure involves on-line coupling of extraction with Cyclone P (50 mm x 0.5 mm 50 microm) HTLC column by injecting 15 microL sample and chromatographic separation is performed with Cohesive Propel C18 (5 microm, 3.0 mm x 50 mm), followed by quantification with mass detector in SRM mode using ESI as an interface. The calibration curves were linear over a concentration range of 0.1-8 ng/mL of Clopidogrel and 70 ng/mL to 6 microg/mL of its metabolite using 20 mL human plasma per batch. The total run time of analysis was 7.5 min and the lower limits of quantification were 0.1 ng/mL for Clopidogrel and 70 ng/mL for its metabolite. The method validation was carried out in terms of specificity, sensitivity, linearity, precision, accuracy and stability. The validated method was applied in bioavailability and bioequivalence study.
(2009 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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