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Validated quantification method for five ephedrines in dietary supplements using LC-MS/MS: Application to 503 cases.

Jianli Zhang1, Yinong Zhang2, Yan Wang3

  • 1State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100050, China; China Anti-Doping Agency, Beijing 100029, China.

Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
|November 16, 2016
PubMed
Summary

A new LC-MS/MS method accurately quantifies ephedrines in dietary supplements, detecting herbal sources and illegal adulteration. This validated method ensures product safety and regulatory compliance for ephedrine and related compounds.

Keywords:
Dietary supplementsDoping-controlEphedrine alkaloidsliquid chromatography tandem mass spectrometry (LC-MS/MS)

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Area of Science:

  • Analytical Chemistry
  • Food Science and Technology
  • Pharmacology

Background:

  • Ephedrines, found in dietary supplements, can originate from natural sources or illicit adulteration.
  • Accurate quantification of ephedrines is crucial for ensuring product safety and regulatory compliance.
  • Existing analytical methods may face challenges in separating and quantifying structurally similar ephedrine isomers.

Purpose of the Study:

  • To develop and validate a robust liquid chromatography-tandem mass spectrometry (LC-MS/MS) method.
  • To enable the separation and quantification of key ephedrine compounds (ephedrine, pseudoephedrine, norephedrine, nore pseudoephedrine, methyl-ephedrine).
  • To analyze ephedrines across diverse dietary supplement matrices (solid, liquid, oil).

Main Methods:

  • Liquid-liquid extraction was employed to isolate ephedrines from solid, liquid, and oil matrices.
  • Liquid chromatography (LC) was utilized for the chromatographic separation of ephedrine isomers.
  • Triple quadrupole mass spectrometry (MS/MS) with positive electrospray ionization in multi-reaction monitoring (MRM) mode was used for detection and quantification.

Main Results:

  • The method demonstrated good recoveries across all matrices: 53.3-91.5% (solid), 56.4-102.3% (liquid), and 51.7-101.2% (oil).
  • Linearity ranges were established as 10-1000 ng/g (solid/oil) and 1-100 ng/ml (liquid).
  • High accuracy (-11.5-16.3%) and low intra-day (<5.9%) and inter-day (<7.3%) variations were achieved, with expanded uncertainty <0.158 ng/g.

Conclusions:

  • The developed LC-MS/MS method is suitable for the reliable quantification of ephedrines in various dietary supplement formulations.
  • This analytical approach can effectively differentiate and quantify ephedrine isomers, aiding in the detection of adulteration.
  • The validated method provides a valuable tool for quality control and regulatory monitoring of dietary supplements.