Development of a Quantitative Chromatographic Fingerprint Analysis Method for Sugar Components of Xiaochaihu Capsules Based on Quality by Design Concept
Background: Xiaochaihu capsule is composed of seven traditional Chinese medicines. The pharmacopoeia only focuses on the quantitative detection of baicalin, which cannot fully reflect the quality of the preparation. Some medium polar components were used to establish the fingerprint of Xiaochaihu ca...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2022-12-01
|
| Series: | Separations |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2297-8739/10/1/13 |
| _version_ | 1797437153926447104 |
|---|---|
| author | Jing Lan Gelin Wu Linlin Wu Haibin Qu Ping Gong Yongjian Xie Peng Zhou Xingchu Gong |
| author_facet | Jing Lan Gelin Wu Linlin Wu Haibin Qu Ping Gong Yongjian Xie Peng Zhou Xingchu Gong |
| author_sort | Jing Lan |
| collection | DOAJ |
| description | Background: Xiaochaihu capsule is composed of seven traditional Chinese medicines. The pharmacopoeia only focuses on the quantitative detection of baicalin, which cannot fully reflect the quality of the preparation. Some medium polar components were used to establish the fingerprint of Xiaochaihu capsule, but there was no report on the strong polar components. Methods: A high performance liquid chromatography-corona charged aerosol detection technology was used to establish a fingerprint analysis method for Xiaochaihu capsules following an analytical quality by design approach. Definitive screening designed experiments were used to optimize the method parameters. A stepwise regression method was used to build quantitative models. The method operable design region was calculated using the experimental error simulation method. Plackett–Burman designed experiments were carried out to test robustness. Results: The contents of four components were simultaneously determined. There were seven common peaks in the fingerprint. The common peak area accounted for 91.72%. Both fingerprint and quantitative analysis methods were validated as applicable in the methodology study. The quantitative fingerprint analysis method for sugar components can fill the gap in the detection of strong polar components in the existing methods. It provides a new technology for the comprehensive overall evaluation of Xiaochaihu capsule. |
| first_indexed | 2024-03-09T11:14:44Z |
| format | Article |
| id | doaj.art-382d3bb6729b4031a48e5384323f6ce7 |
| institution | Directory Open Access Journal |
| issn | 2297-8739 |
| language | English |
| last_indexed | 2024-03-09T11:14:44Z |
| publishDate | 2022-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Separations |
| spelling | doaj.art-382d3bb6729b4031a48e5384323f6ce72023-12-01T00:32:07ZengMDPI AGSeparations2297-87392022-12-011011310.3390/separations10010013Development of a Quantitative Chromatographic Fingerprint Analysis Method for Sugar Components of Xiaochaihu Capsules Based on Quality by Design ConceptJing Lan0Gelin Wu1Linlin Wu2Haibin Qu3Ping Gong4Yongjian Xie5Peng Zhou6Xingchu Gong7Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, ChinaZhejiang Pralife Pharmaceutical Co., Ltd., Taizhou 318000, ChinaPharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, ChinaPharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, ChinaZhejiang Pralife Pharmaceutical Co., Ltd., Taizhou 318000, ChinaZhejiang Pralife Pharmaceutical Co., Ltd., Taizhou 318000, ChinaZhejiang Pralife Pharmaceutical Co., Ltd., Taizhou 318000, ChinaPharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, ChinaBackground: Xiaochaihu capsule is composed of seven traditional Chinese medicines. The pharmacopoeia only focuses on the quantitative detection of baicalin, which cannot fully reflect the quality of the preparation. Some medium polar components were used to establish the fingerprint of Xiaochaihu capsule, but there was no report on the strong polar components. Methods: A high performance liquid chromatography-corona charged aerosol detection technology was used to establish a fingerprint analysis method for Xiaochaihu capsules following an analytical quality by design approach. Definitive screening designed experiments were used to optimize the method parameters. A stepwise regression method was used to build quantitative models. The method operable design region was calculated using the experimental error simulation method. Plackett–Burman designed experiments were carried out to test robustness. Results: The contents of four components were simultaneously determined. There were seven common peaks in the fingerprint. The common peak area accounted for 91.72%. Both fingerprint and quantitative analysis methods were validated as applicable in the methodology study. The quantitative fingerprint analysis method for sugar components can fill the gap in the detection of strong polar components in the existing methods. It provides a new technology for the comprehensive overall evaluation of Xiaochaihu capsule.https://www.mdpi.com/2297-8739/10/1/13quality by designXiaochaihu capsulequantitative chromatographic fingerprintdesign spacedefinitive screening designPlackett–Burman |
| spellingShingle | Jing Lan Gelin Wu Linlin Wu Haibin Qu Ping Gong Yongjian Xie Peng Zhou Xingchu Gong Development of a Quantitative Chromatographic Fingerprint Analysis Method for Sugar Components of Xiaochaihu Capsules Based on Quality by Design Concept Separations quality by design Xiaochaihu capsule quantitative chromatographic fingerprint design space definitive screening design Plackett–Burman |
| title | Development of a Quantitative Chromatographic Fingerprint Analysis Method for Sugar Components of Xiaochaihu Capsules Based on Quality by Design Concept |
| title_full | Development of a Quantitative Chromatographic Fingerprint Analysis Method for Sugar Components of Xiaochaihu Capsules Based on Quality by Design Concept |
| title_fullStr | Development of a Quantitative Chromatographic Fingerprint Analysis Method for Sugar Components of Xiaochaihu Capsules Based on Quality by Design Concept |
| title_full_unstemmed | Development of a Quantitative Chromatographic Fingerprint Analysis Method for Sugar Components of Xiaochaihu Capsules Based on Quality by Design Concept |
| title_short | Development of a Quantitative Chromatographic Fingerprint Analysis Method for Sugar Components of Xiaochaihu Capsules Based on Quality by Design Concept |
| title_sort | development of a quantitative chromatographic fingerprint analysis method for sugar components of xiaochaihu capsules based on quality by design concept |
| topic | quality by design Xiaochaihu capsule quantitative chromatographic fingerprint design space definitive screening design Plackett–Burman |
| url | https://www.mdpi.com/2297-8739/10/1/13 |
| work_keys_str_mv | AT jinglan developmentofaquantitativechromatographicfingerprintanalysismethodforsugarcomponentsofxiaochaihucapsulesbasedonqualitybydesignconcept AT gelinwu developmentofaquantitativechromatographicfingerprintanalysismethodforsugarcomponentsofxiaochaihucapsulesbasedonqualitybydesignconcept AT linlinwu developmentofaquantitativechromatographicfingerprintanalysismethodforsugarcomponentsofxiaochaihucapsulesbasedonqualitybydesignconcept AT haibinqu developmentofaquantitativechromatographicfingerprintanalysismethodforsugarcomponentsofxiaochaihucapsulesbasedonqualitybydesignconcept AT pinggong developmentofaquantitativechromatographicfingerprintanalysismethodforsugarcomponentsofxiaochaihucapsulesbasedonqualitybydesignconcept AT yongjianxie developmentofaquantitativechromatographicfingerprintanalysismethodforsugarcomponentsofxiaochaihucapsulesbasedonqualitybydesignconcept AT pengzhou developmentofaquantitativechromatographicfingerprintanalysismethodforsugarcomponentsofxiaochaihucapsulesbasedonqualitybydesignconcept AT xingchugong developmentofaquantitativechromatographicfingerprintanalysismethodforsugarcomponentsofxiaochaihucapsulesbasedonqualitybydesignconcept |