A pharmacokinetic study of ephedrine and pseudoephedrine after oral administration of ojeok-san by validated LC-MS/MS method in human plasma

Sooyoung Lee; Wang Seob Shim; Heejo Yoo; Sanghee Choi; Jiyoung Yoon; Kwang Young Lee; Eun Kyoung Chung; Byung Cheol Lee; Sung Vin Yim; Bo Hyung Kim; Kyung Tae Lee

doi:10.3390/molecules26226991

A pharmacokinetic study of ephedrine and pseudoephedrine after oral administration of ojeok-san by validated LC-MS/MS method in human plasma

Sooyoung Lee, Wang Seob Shim, Heejo Yoo, Sanghee Choi, Jiyoung Yoon, Kwang Young Lee, Eun Kyoung Chung, Byung Cheol Lee, Sung Vin Yim, Bo Hyung Kim, Kyung Tae Lee

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

Abstract

A sensitive and reproducible liquid chromatography-tandem mass spectrometry (LCMS/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.

Original language	English
Article number	6991
Journal	Molecules
Volume	26
Issue number	22
DOIs	https://doi.org/10.3390/molecules26226991
Publication status	Published - 1 Nov 2021

Bibliographical note

Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.

Keywords

Bioanalytical method validation
Ephedrine
Healthy volunteers
Liquid chromatography-tandem mass spectrometry
Pharmacokinetics
Pseudoephedrine

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This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.3390/molecules26226991

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title = "A pharmacokinetic study of ephedrine and pseudoephedrine after oral administration of ojeok-san by validated LC-MS/MS method in human plasma",

abstract = "A sensitive and reproducible liquid chromatography-tandem mass spectrometry (LCMS/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.",

keywords = "Bioanalytical method validation, Ephedrine, Healthy volunteers, Liquid chromatography-tandem mass spectrometry, Pharmacokinetics, Pseudoephedrine",

author = "Sooyoung Lee and Shim, {Wang Seob} and Heejo Yoo and Sanghee Choi and Jiyoung Yoon and Lee, {Kwang Young} and Chung, {Eun Kyoung} and Lee, {Byung Cheol} and Yim, {Sung Vin} and Kim, {Bo Hyung} and Lee, {Kyung Tae}",

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doi = "10.3390/molecules26226991",

language = "English",

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AU - Lee, Sooyoung

AU - Shim, Wang Seob

AU - Yoo, Heejo

AU - Choi, Sanghee

AU - Yoon, Jiyoung

AU - Lee, Kwang Young

AU - Chung, Eun Kyoung

AU - Lee, Byung Cheol

AU - Yim, Sung Vin

AU - Kim, Bo Hyung

AU - Lee, Kyung Tae

PY - 2021/11/1

Y1 - 2021/11/1

N2 - A sensitive and reproducible liquid chromatography-tandem mass spectrometry (LCMS/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.

AB - A sensitive and reproducible liquid chromatography-tandem mass spectrometry (LCMS/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.

KW - Bioanalytical method validation

KW - Ephedrine

KW - Healthy volunteers

KW - Liquid chromatography-tandem mass spectrometry

KW - Pharmacokinetics

KW - Pseudoephedrine

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DO - 10.3390/molecules26226991

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AN - SCOPUS:85121036310

SN - 1420-3049

VL - 26

JO - Molecules

JF - Molecules

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M1 - 6991

ER -

A pharmacokinetic study of ephedrine and pseudoephedrine after oral administration of ojeok-san by validated LC-MS/MS method in human plasma

Abstract

Bibliographical note

Keywords

UN SDGs

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