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Preparation and Certification of a New Salvianolic Acid A Reference Material for Food and Drug Research.
Nat Prod Bioprospect ; 2020 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-32306209
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 342009 and 352005, a Sal A reference material was certified, covering homogeneity studies, stability studies, characterization, and uncertainty estimations.

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Texto completo: Disponível Coleções: Bases de dados internacionais Base de dados: MEDLINE Idioma: Inglês Ano de publicação: 2020 Tipo de documento: Artigo