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 20-5.000 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 (t_max)=1 h, half-life (t1/2)=7.01 h, area under curve (AUC)_0-t=7.420 ng h/mL, and AUC_0-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.