PHARMACOKINETIC PROFILE OF 75 MG CLOPIDOGREL IN PLASMA OF INDONESIAN HEALTHY SUBJECTS BY ULTRA HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY
Objective: This study aimed to determine clopidogrel in plasma to obtain its pharmacokinetic profile using ultra-high-performance liquid
chromatography-tandem mass spectrometry (UPLC-MS/MS).
Methods: Clopidogrel analysis was performed in vivo by UPLC-MS/MS using validated methods. Subjects received 75 mg clopidogrel, and plasma
samples were collected at 14 time points after 0 baseline (pre-dose): 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 8, 12, 18, and 24 h.
Results: A linear calibration curve was produced in the range of 20â€“5.000 pg/mL. This method fulfills the criteria for validation according to the
European Medicines Agency guidelines. The obtained pharmacokinetic profile of clopidogrel was as follows: Maximum concentration=1.146 ng/mL,
time at maximum concentration (tmax)=1 h, half-life (tÂ½)=7.01 h, area under curve (AUC)0âˆ’t=7.420 ng h/mL, and AUC0âˆ’t=8.111 ng h/mL.
Conclusion: Clopidogrel analysis using a UPLC/MS-MS system with liquid-liquid extraction method was successfully conducted using plasma samples
from three healthy subjects who administered 75 mg of clopidogrel tablet.
London: European Medicines Agency; 2009.
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