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High-performance liquid chromatographic determination of inactive carboxylic acid metabolite of clopidogrel in human serum: Application to a bioequivalence study.

Author(s): Bahrami G, Mohammadi B, Sisakhtnezhad S

Affiliation(s): Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; School of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran.

Publication date & source: 2008-03-15, J Chromatogr B Analyt Technol Biomed Life Sci., 864(1-2):168-72. Epub 2008 Feb 8.

A sensitive and rapid method is described for determination of clopidogrel carboxylic acid (CCA), the inactive metabolite of anti platelet agent, clopidogrel, in human serum. The analytical procedure involves liquid-liquid extraction of the analyte and an internal standard (phenytoin) with ethyl acetate. A mobile phase consisting of 0.05M phosphate buffer containing triethylamine (0.5mL/L; pH 5.7) and acetonitrile (56:44 v/v) was used and chromatographic separation was achieved using C18 analytical column at detector wavelength of 220nm. The calibration curves were linear over a concentration range of 0.05-10mug/mL of CCA in human serum. The total run time of analysis was 5.5min and the lower limits of detection (LOD) and quantification (LOQ) were 0.02 and 0.05mug/mL, respectively. The method validation was carried out in terms of specificity, sensitivity, linearity, precision, accuracy and stability. The validated method was applied in a randomized cross-over bioequivalence study of two different clopidogrel preparations in 24 healthy volunteers.

Page last updated: 2008-03-26

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