Quantitative chromatographic fingerprint analysis of Sanye Tangzhiqing Decoction based on quality by design concept.
10.19540/j.cnki.cjcmm.20190804.302
- Author:
Jing-Yuan SHAO
1
;
Jun-Lin GUO
2
;
Shang-Xin GUO
1
;
Zhi-Heng SHU
1
;
Hai-Bin QU
1
;
Xing-Chu GONG
3
Author Information
1. Pharmaceutical Informatics Institute,College of Pharmaceutical Sciences,Zhejiang University Hangzhou 310058,China.
2. Graduate School,Tianjin University of Traditional Chinese Medicine Tianjin 300193,China.
3. Pharmaceutical Informatics Institute,College of Pharmaceutical Sciences,Zhejiang University Hangzhou 310058,China Graduate School,Tianjin University of Traditional Chinese Medicine Tianjin 300193,China.
- Publication Type:Journal Article
- Keywords:
Sanye Tangzhiqing Decoction;
definitive screening design;
design space;
quality by design;
quantitative chromatographic fingerprint
- MeSH:
Chlorogenic Acid;
Chromatography, High Pressure Liquid;
Drugs, Chinese Herbal
- From:
China Journal of Chinese Materia Medica
2019;44(22):4844-4851
- CountryChina
- Language:Chinese
-
Abstract:
In this work,a high performance liquid chromatography-ultraviolet( HPLC-UV) detection technology was used to establish fingerprint analysis method for Sanye Tangzhiqing Decoction following an analytical quality by design( AQb D) approach. Firstly,column temperature,flow rate,and gradient elution conditions were determined as the method parameters needing to be optimized. Then according to the results of definitive screening design,three critical method attributes( CMAs) were identified,including peak number,the percentage of common peak area to total peak area,and retention time of the last peak. A stepwise regression method was used then to build quantitative models between CMAs and method parameters. Probability-based design space was calculated and successfully verified using the experimental error simulation method. After the analysis conditions were optimized,the contents of six components,namely chlorogenic acid,paeoniflorin,rutin,hyperoside,quercetin-3-O-β-D-glucuronide,and salvianolic acid B were simultaneously determined. There were 19 common peaks in the fingerprint and their common peak area accounted for 96% of the total peak area. Both fingerprint and quantitative analysis methods were validated applicable in methodology study,and they can be applied to determine new samples.
