Abstract
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.
Highlights
Q1 full-scan spectra were characterized by protonated molecules [M + H]+ at m/z 166.2 for ephedrine and pseudoephedrine and m/z 121.98 for internal standard (IS)
The selected product ions were m/z 148.2 for both ephedrine and pseudoephedrine; m/z 105.0 was selected for the IS (Figure 1)
The newly developed LC-MS/MS method, which is simple and sufficiently sensitive, was comprehensively validated according to the MFDS and the U.S Food and Drug Administration (FDA) guidelines and was successfully used to simultaneously determine ephedrine and pseudoephedrine in human plasma following the oral administration of OJS powder (14.47 g/pack) with water
Summary
As herbal medicines are gaining momentum worldwide [1], the number of patients taking prescribed herbal medicines is simultaneously growing [2]. According to statistical data of the Health Insurance Review and Assessment Service, among 56 herbal prescriptions, Ojeok-san (OJS; wuji-power in China and goshakusan in Japan) was the most commonly prescribed herbal medicine in 2013. OJS is composed of 15 medicinal herbs: Atractylodes lancea D.C., Ephedra sinica Stapf, Citrus unshiu Markovich, Magnolia officinalis Rehd. DC., Angelica gigas Nakai, Zingiber officinale Rosc., Paeonia lactiflora Pall., Poria cocos Wolf, Cnidium officinale Makino, Angelica dahurica Benth. DC., Angelica gigas Nakai, Zingiber officinale Rosc., Paeonia lactiflora Pall., Poria cocos Wolf, Cnidium officinale Makino, Angelica dahurica Benth. et Hook
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