Determination of clopidogrel in human plasma by liquid chromatography/tandem mass spectrometry: application to a clinical pharmacokinetic study

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Abstract
A rapid and sensitive LC/MS/MS assay was developed and validated for the determination of clopidogrel in human plasma. Clopidogrel was extracted by single liquid–liquid extraction with pentane, and chromatographic separations were achieved on a C18column. The method was validated to demonstrate the specificity, linearity, recovery, lower limit of quantification (LLOQ), stability, accuracy and precision. The multiple reaction monitoring was based onm/ztransition of 322.2 → 211.9 for clopidogrel and 264.1 → 125.1 for ticlopidine (internal standard). The total analytical run time was relatively short (3 min), and the LLOQ was 10 pg/mL using 0.5 mL of human plasma. The assay was linear over a concentration range from 10 to 10,000 pg/mL (r> 0.999). The intra‐ and inter‐day accuracies were 101.3–108.8 and 98.4–103.5%, respectively, and the intra‐ and inter‐day assay precisions were 1.9–5.5 and 4.4–8.1%, respectively. The developed assay method was applied to a pharmacokinetic study in human volunteers after oral administration of clopidogrel at a dose of 150 mg. Copyright © 2007 John Wiley & Sons, Ltd.