Two flavone C -glycosides as quality control markers for the manufacturing process of ephedrine alkaloids-free Ephedra Herb extract (EFE) as a crude drug preparation

AbstractAs part of our continuing study of ephedrine alkaloids-free Ephedra Herb extract (EFE) in pursuit of its approval as a crude drug preparation, we identified two quantitative markers for the quality control of the manufacturing process of EFE and sought to establish cost-effective and simple methods for quantitative analyses. We analysed Ephedra Herb extracts grown in different habitats and collection years by liquid chromatography/high-resolution mass spectrometry (LC/HRMS) and detected two notable peaks common to each extract. These peaks were identified as vicenin-2 (1) and isovitexin 2 ″-O-rhamnoside (2). Quantitative analyses using the isocratic condition of LC/MS showed that the content percentages of1 and2 in EFE were 0.140 –0.146% and 0.350–0.411%, respectively. We concluded that1 and2 were adequate quality control markers for quantitative analysis of EFE. Furthermore, we quantitatively analysed apigenin (3), an aglycon common to1 and2, and found that the conversion factors of1 to3 and2 to3 were 1.3 and 1.5, respectively. Therefore, we concluded that3 was a secondary standard for quantifying the contents of1 and2 in EFE. A series of results obtained from this study will be valuable for the quality control of EFE.
Source: Journal of Natural Medicines - Category: Drugs & Pharmacology Source Type: research