Preparation and Certification of a New Salvianolic Acid A Reference Material for Food and Drug Research
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...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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SpringerOpen
2020-04-01
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| Series: | Natural Products and Bioprospecting |
| Subjects: | |
| Online Access: | https://doi.org/10.1007/s13659-020-00236-2 |
| _version_ | 1818446504470249472 |
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| author | Dezhi Yang Bin Su Yancai Bi Li Zhang Baoxi Zhang Junke Song Yang Lu Guanhua Du |
| author_facet | Dezhi Yang Bin Su Yancai Bi Li Zhang Baoxi Zhang Junke Song Yang Lu Guanhua Du |
| author_sort | Dezhi Yang |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-14T19:48:47Z |
| format | Article |
| id | doaj.art-e3f20d58bd324bfa95c1d81815e43dc6 |
| institution | Directory Open Access Journal |
| issn | 2192-2195 2192-2209 |
| language | English |
| last_indexed | 2024-12-14T19:48:47Z |
| publishDate | 2020-04-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Natural Products and Bioprospecting |
| spelling | doaj.art-e3f20d58bd324bfa95c1d81815e43dc62022-12-21T22:49:29ZengSpringerOpenNatural Products and Bioprospecting2192-21952192-22092020-04-01102677510.1007/s13659-020-00236-2Preparation and Certification of a New Salvianolic Acid A Reference Material for Food and Drug ResearchDezhi Yang0Bin Su1Yancai Bi2Li Zhang3Baoxi Zhang4Junke Song5Yang Lu6Guanhua Du7Beijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical CollegeSoteria Pharmaceutical Co., Ltd.Soteria Pharmaceutical Co., Ltd.Beijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing City Key Laboratory of Drug Target and Screening Research, National Center for Pharmaceutical Screening, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing City Key Laboratory of Drug Target and Screening Research, National Center for Pharmaceutical Screening, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical CollegeAbstract 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 Abstracthttps://doi.org/10.1007/s13659-020-00236-2Certified reference materialSalvianolic acid AMass balance methodqNMRHigh resolution mass spectrum |
| spellingShingle | Dezhi Yang Bin Su Yancai Bi Li Zhang Baoxi Zhang Junke Song Yang Lu Guanhua Du Preparation and Certification of a New Salvianolic Acid A Reference Material for Food and Drug Research Natural Products and Bioprospecting Certified reference material Salvianolic acid A Mass balance method qNMR High resolution mass spectrum |
| title | Preparation and Certification of a New Salvianolic Acid A Reference Material for Food and Drug Research |
| title_full | Preparation and Certification of a New Salvianolic Acid A Reference Material for Food and Drug Research |
| title_fullStr | Preparation and Certification of a New Salvianolic Acid A Reference Material for Food and Drug Research |
| title_full_unstemmed | Preparation and Certification of a New Salvianolic Acid A Reference Material for Food and Drug Research |
| title_short | Preparation and Certification of a New Salvianolic Acid A Reference Material for Food and Drug Research |
| title_sort | preparation and certification of a new salvianolic acid a reference material for food and drug research |
| topic | Certified reference material Salvianolic acid A Mass balance method qNMR High resolution mass spectrum |
| url | https://doi.org/10.1007/s13659-020-00236-2 |
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