Molecules (Nov 2021)

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
https://doi.org/10.3390/molecules26226991
Journal volume & issue
Vol. 26, no. 22
p. 6991

Abstract

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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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