A Pharmacokinetic Study of Ephedrine and Pseudoephedrine after Oral Administration of Ojeok-San by Validated LC-MS/MS Method in Human Plasma

A Pharmacokinetic Study of Ephedrine and Pseudoephedrine after Oral Administration of Ojeok-San by Validated LC-MS/MS Method in Human Plasma

A sensitive and reproducible liquid chromatography-tandem mass spectrometry (LC-MS/MS) system was developed and fully validated for the simultaneous determination of ephedrine and pseudoephedrine in human plasma after oral administration of the herbal prescription Ojeok-san (OJS); 2-phenylethylamine...

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Bibliographic Details
Published in:Molecules (Basel, Switzerland) Vol. 26; no. 22; p. 6991
Main Authors: Lee, Sooyoung, Shim, Wang-Seob, Yoo, Heejo, Choi, Sanghee, Yoon, Jiyoung, Lee, Kwang-Young, Chung, Eun-Kyoung, Lee, Byung-Cheol, Yim, Sung-Vin, Kim, Bo-Hyung, Lee, Kyung-Tae
Format: Journal Article
Language:English
Published: Basel MDPI AG 19-11-2021
MDPI
Subjects:
Accuracy
bioanalytical method validation
Blood plasma
Calibration
Caustic soda
Chloride
Chromatography
Ephedrine
healthy volunteers
Herbal medicine
Ions
Liquid chromatography
liquid chromatography-tandem mass spectrometry
Mass spectrometry
Mass spectroscopy
Oral administration
Pharmacokinetics
Pharmacology
Pharmacovigilance
Phenethylamine
Phenylethylamine
Plasma
pseudoephedrine
Quantitation
Scientific imaging
Selectivity
Solvents
China
Japan
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Summary:A sensitive and reproducible liquid chromatography-tandem mass spectrometry (LC-MS/MS) system was developed and fully validated for the simultaneous determination of ephedrine and pseudoephedrine in human plasma after oral administration of the herbal prescription Ojeok-san (OJS); 2-phenylethylamine was used as the internal standard (IS). Both compounds presented a linear calibration curve (r2 ≥ 0.99) over a concentration range of 0.2–50 ng/mL. The developed method was fully validated in terms of selectivity, lower limit of quantitation, precision, accuracy, recovery, matrix effect, and stability, according to the regulatory guidelines from the U.S. Food and Drug Administration and the Korea Ministry of Food and Drug Safety. This validated method was successfully applied for the pharmacokinetic assessment of ephedrine and pseudoephedrine in 20 healthy Korean volunteers administered OJS.
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These authors contributed equally to the first authors.
ISSN:1420-3049
1420-3049
DOI:10.3390/molecules26226991