PHARMACOKINETIC PROFILE OF 75 MG CLOPIDOGREL IN PLASMA OF INDONESIAN HEALTHY SUBJECTS BY ULTRA HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY


Yahdiana Harahap, Ganesya Rita Putri, Herman Suryadi

Abstract


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 (t½)=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.


Keywords


Clopidogrel, Ultra-high-performance liquid chromatography-tandem mass spectrometry, Plasma, Pharmacokinetic profile, Bioanalysis.

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About this article

Title

PHARMACOKINETIC PROFILE OF 75 MG CLOPIDOGREL IN PLASMA OF INDONESIAN HEALTHY SUBJECTS BY ULTRA HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY

Keywords

Clopidogrel, Ultra-high-performance liquid chromatography-tandem mass spectrometry, Plasma, Pharmacokinetic profile, Bioanalysis.

DOI

10.22159/ijap.2018.v10s1.73

Date

20-12-2018

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol. 10, Special Issue 1 (Dec.), 2018 Page: 331-334

Online ISSN

0975-7058

Authors & Affiliations

Yahdiana Harahap
Department of Bioavailability/Bioequivalence Laboratory, Faculty of Pharmacy, Universitas Indonesia, Depok, 16424, Indonesia.

Ganesya Rita Putri
Department of Bioavailability/Bioequivalence Laboratory, Faculty of Pharmacy, Universitas Indonesia, Depok, 16424, Indonesia.

Herman Suryadi
Department of Bioavailability/Bioequivalence Laboratory, Faculty of Pharmacy, Universitas Indonesia, Depok, 16424, Indonesia.


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