Department of Biomedical and Pharmaceutical Sciences, Graduate School, Kyung Hee University, Seoul 02447, Korea.
Kyung Hee Drug Analysis Center, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea.
Molecules. 2021 Nov 19;26(22):6991. doi: 10.3390/molecules26226991.
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 ( ≥ 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.
建立并充分验证了一种灵敏且重现的液相色谱-串联质谱（LC-MS/MS）检测方法，用于测定口服草药处方 Ojeok-san（OJS）后人体血浆中麻黄碱和伪麻黄碱的浓度：2-苯乙胺作为内标（IS）。两种化合物在 0.2-50ng/mL 浓度范围内均呈现良好的线性关系（≥0.99）。该方法经过美国食品药品监督管理局（FDA）和韩国食品药品安全部（MFDS）法规指南的全面验证，包括专属性、定量下限、精密度、准确度、回收率、基质效应和稳定性。该方法成功应用于 20 名健康韩国志愿者口服 OJS 后的药代动力学评估。
