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Development of a comprehensive method combining UHPLC-CAD fingerprint, multi-components quantitative analysis for quality evaluation of Zishen Yutai Pills: A step towards quality control of Chinese patent medicine
Cao,Jiliang1,2,3; Lei,Ting4; Wu,Sijia2; Li,Hongyi2; Deng,Yun3; Lin,Ruizhen4; Ning,Na4; Geng,Chunxian4; Wang,Shengpeng2; Wu,Xu5; Li,Peng2; Wang,Yitao2
2020-11-30
Source PublicationJournal of Pharmaceutical and Biomedical Analysis
ISSN0731-7085
Volume191
Abstract

Zishen Yutai Pills (ZYP) is a well-known Chinese patent medicine which has been used to prevent recurrent miscarriage and treat threatened abortion in China. In this study, a comprehensive strategy combining ultrahigh performance liquid chromatography coupled with charged aerosol detector (UHPLC-CAD) fingerprint and multi-components quantitative analysis was developed and validated for quality evaluation of ZYP. For fingerprint analysis, a total of 52 characteristic peaks were selected to evaluate the similarities of 16 batches of ZYP. In addition, combining the chemical fingerprint profile with an advanced hybrid LTQ-Orbitrap mass spectrometer, 281 compounds were identified or tentatively identified in ZYP based on chemical standards, accurate mass and fragmentation information. Moreover, 18 chemical markers were simultaneously determined within 13 min by ultra-performance liquid chromatography couple to tandem mass spectrometry (UPLC-MS/MS) with positive-negative conversion multiple reaction monitor (+/-MRM) technique. This method has been validated and exhibited satisfactory sensitivity, precision, reproducibility and accuracy. The validated quantitative method was successfully applied to the analysis of 16 batches of ZYP samples. The combination of UHPLC-CAD fingerprint and multi-components quantification has been proved to be an efficient and reliable strategy for quality control of ZYP and could be considered as a reference for quality evaluation of Chinese patent medicine.

KeywordChemical Characterization Chemical Fingerprint Multi-components Quantitative Analysis Quality Evaluation Zishen Yutai Pills
DOI10.1016/j.jpba.2020.113570
URLView the original
Indexed BySCIE
WOS Research AreaChemistry ; Pharmacology & Pharmacy
WOS SubjectChemistry, Analytical ; Pharmacology & Pharmacy
WOS IDWOS:000579528000013
Scopus ID2-s2.0-85090192673
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Cited Times [WOS]:5   [WOS Record]     [Related Records in WOS]
Document TypeJournal article
CollectionInstitute of Chinese Medical Sciences
Corresponding AuthorWu,Xu; Li,Peng
Affiliation1.PU-UM Innovative Institute of Chinese Medical Sciences,Guangdong-Macau Traditional Chinese Medicine Technology Industrial Park Development Co.,Ltd,Zhuhai,Hengqin New Area,China
2.State Key Laboratory of Quality Research in Chinese Medicine,Institute of Chinese Medical Sciences,University of Macau,Taipa,China
3.College of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu,China
4.Guangzhou Baiyunshan Zhongyi Pharmaceutical Co.,Ltd,Guangzhou,China
5.Laboratory of Molecular Pharmacology,Department of Pharmacology,School of Pharmacy,Southwest Medical University,Luzhou,China
First Author AffilicationInstitute of Chinese Medical Sciences
Corresponding Author AffilicationInstitute of Chinese Medical Sciences
Recommended Citation
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Cao,Jiliang,Lei,Ting,Wu,Sijia,et al. Development of a comprehensive method combining UHPLC-CAD fingerprint, multi-components quantitative analysis for quality evaluation of Zishen Yutai Pills: A step towards quality control of Chinese patent medicine[J]. Journal of Pharmaceutical and Biomedical Analysis,2020,191.
APA Cao,Jiliang,Lei,Ting,Wu,Sijia,Li,Hongyi,Deng,Yun,Lin,Ruizhen,Ning,Na,Geng,Chunxian,Wang,Shengpeng,Wu,Xu,Li,Peng,&Wang,Yitao.(2020).Development of a comprehensive method combining UHPLC-CAD fingerprint, multi-components quantitative analysis for quality evaluation of Zishen Yutai Pills: A step towards quality control of Chinese patent medicine.Journal of Pharmaceutical and Biomedical Analysis,191.
MLA Cao,Jiliang,et al."Development of a comprehensive method combining UHPLC-CAD fingerprint, multi-components quantitative analysis for quality evaluation of Zishen Yutai Pills: A step towards quality control of Chinese patent medicine".Journal of Pharmaceutical and Biomedical Analysis 191(2020).
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