Preparation and Certification of a New Salvianolic Acid A Reference Material for Food and Drug Research

• Main Authors: Dezhi Yang, Bin Su, Yancai Bi, Li Zhang, Baoxi Zhang, Junke Song, Yang Lu, Guanhua Du
• Format: Article
• Language: English
• Published: SpringerOpen 2020-04-01
• Series: Natural Products and Bioprospecting
• Subjects: Certified reference material; Salvianolic acid A; Mass balance method; qNMR; High resolution mass spectrum
• Online Access: https://doi.org/10.1007/s13659-020-00236-2
• ISSN: 2192-2195; 2192-2209

Abstract Salvianolic acid A (Sal A), a water-soluble ingredient in Danshen, has various biological activities. Sal A and its impurities have similar physical and chemical properties, as well as strong reducibility; therefore, they are difficult to prepare and purify. In this study, high-purity Sal A was obtained by purification of sephadex chromatography and preparative chromatography. Furthermore, HPLC–DAD tandem ECD and HPLC–DAD tandem MS methods were used for non-volatile organic impurity analysis, ICP-MS method was used for non-volatile inorganic impurities and mass balance method and quantitative nuclear magnetic resonance were employed to certify the product. The structures of Sal A and its relative impurities were validated by nuclear magnetic resonance spectroscopy and mass spectrometry, and their contents were quantified as well. Following the principles of ISO Guides 34:2009 and 35:2005, a Sal A reference material was certified, covering homogeneity studies, stability studies, characterization, and uncertainty estimations. Graphic Abstract