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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Autores principales: 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
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Publicado: MDPI AG 2021
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Acceso en línea:https://doaj.org/article/e90ab1bdd10343f495d7e182cba62878
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spelling oai:doaj.org-article:e90ab1bdd10343f495d7e182cba628782021-11-25T18:28:58ZA Pharmacokinetic Study of Ephedrine and Pseudoephedrine after Oral Administration of Ojeok-San by Validated LC-MS/MS Method in Human Plasma10.3390/molecules262269911420-3049https://doaj.org/article/e90ab1bdd10343f495d7e182cba628782021-11-01T00:00:00Zhttps://www.mdpi.com/1420-3049/26/22/6991https://doaj.org/toc/1420-3049A 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 (<i>r</i><sup>2</sup> ≥ 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.Sooyoung LeeWang-Seob ShimHeejo YooSanghee ChoiJiyoung YoonKwang-Young LeeEun-Kyoung ChungByung-Cheol LeeSung-Vin YimBo-Hyung KimKyung-Tae LeeMDPI AGarticleephedrinepseudoephedrineliquid chromatography-tandem mass spectrometrybioanalytical method validationpharmacokineticshealthy volunteersOrganic chemistryQD241-441ENMolecules, Vol 26, Iss 6991, p 6991 (2021)
institution DOAJ
collection DOAJ
language EN
topic ephedrine
pseudoephedrine
liquid chromatography-tandem mass spectrometry
bioanalytical method validation
pharmacokinetics
healthy volunteers
Organic chemistry
QD241-441
spellingShingle ephedrine
pseudoephedrine
liquid chromatography-tandem mass spectrometry
bioanalytical method validation
pharmacokinetics
healthy volunteers
Organic chemistry
QD241-441
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
A Pharmacokinetic Study of Ephedrine and Pseudoephedrine after Oral Administration of Ojeok-San by Validated LC-MS/MS Method in Human Plasma
description 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 (<i>r</i><sup>2</sup> ≥ 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.
format article
author 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
author_facet 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
author_sort Sooyoung Lee
title A Pharmacokinetic Study of Ephedrine and Pseudoephedrine after Oral Administration of Ojeok-San by Validated LC-MS/MS Method in Human Plasma
title_short A Pharmacokinetic Study of Ephedrine and Pseudoephedrine after Oral Administration of Ojeok-San by Validated LC-MS/MS Method in Human Plasma
title_full A Pharmacokinetic Study of Ephedrine and Pseudoephedrine after Oral Administration of Ojeok-San by Validated LC-MS/MS Method in Human Plasma
title_fullStr A Pharmacokinetic Study of Ephedrine and Pseudoephedrine after Oral Administration of Ojeok-San by Validated LC-MS/MS Method in Human Plasma
title_full_unstemmed A Pharmacokinetic Study of Ephedrine and Pseudoephedrine after Oral Administration of Ojeok-San by Validated LC-MS/MS Method in Human Plasma
title_sort pharmacokinetic study of ephedrine and pseudoephedrine after oral administration of ojeok-san by validated lc-ms/ms method in human plasma
publisher MDPI AG
publishDate 2021
url https://doaj.org/article/e90ab1bdd10343f495d7e182cba62878
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