TY - JOUR
T1 - Pharmacokinetic profile of 75 mg clopidogrel in plasma of indonesian healthy subjects by ultra high-performance liquid chromatography-tandem mass spectrometry
AU - Harahap, Yahdiana
AU - Putri, Ganesya Rita
AU - Suryadi, Herman
N1 - Publisher Copyright:
© 2018 The Authors.
PY - 2018/12/1
Y1 - 2018/12/1
N2 - 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 (tmax)=1 h, half-life (t1/2)=7.01 h, area under curve (AUC)0-t=7.420 ng h/mL, and AUC0-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.
AB - 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 (tmax)=1 h, half-life (t1/2)=7.01 h, area under curve (AUC)0-t=7.420 ng h/mL, and AUC0-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.
KW - Bioanalysis
KW - Clopidogrel
KW - Pharmacokinetic profile
KW - Plasma
KW - Ultra-high-performance liquid chromatography-tandem mass spectrometry
UR - http://www.scopus.com/inward/record.url?scp=85071856560&partnerID=8YFLogxK
U2 - 10.22159/ijap.2018.v10s1.73
DO - 10.22159/ijap.2018.v10s1.73
M3 - Article
AN - SCOPUS:85071856560
SN - 0975-7058
VL - 10
SP - 331
EP - 334
JO - International Journal of Applied Pharmaceutics
JF - International Journal of Applied Pharmaceutics
IS - Special Issue 1
ER -