| ORIGINAL ARTICLES |
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Preparation and Certification of a New Salvianolic Acid A Reference Material for Food and Drug Research |
| Dezhi Yang1, Bin Su2, Yancai Bi2, Li Zhang1, Baoxi Zhang1, Junke Song3, Yang Lu1, Guanhua Du3 |
1 Beijing City Key Laboratory of Polymorphic Drugs, Center of Pharmaceutical Polymorphs, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, People's Republic of China;
2 Soteria Pharmaceutical Co., Ltd., Laiwu 271100, People's Republic of China;
3 Beijing 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 College, Beijing 100050, People's Republic of China |
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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.
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| Keywords
Certified reference material
Salvianolic acid A
Mass balance method
qNMR
High resolution mass spectrum
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| Fund:The authors acknowledge National Key R&D Program of China (Grant No. 2016YFC1000900), The Drug Innovation Major Project (Grant No. 2018ZX09711001-001-015) should be substituted by Drug Innovation Major Project (Grant No. 2018ZX09711001-003-022) and CAMS Innovation Fund for Medical Sciences (Grant No. 2016-I2M-3-007) for financing this work. |
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Corresponding Authors:
Yang Lu, Guanhua Du
E-mail: luy@imm.ac.cn;dugh@imm.ac.cn
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Issue Date: 06 May 2020
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