Quality evaluation of zhibitai capsules based on high performance liquid chromatography QAMS combined with chemometrics
10.19778/j.chp.2024.06.003
- VernacularTitle:基于高效液相色谱一测多评技术联合化学计量学的脂必泰胶囊质量评价
- Author:
Wanbing YU
1
;
Danli ZHANG
;
Suzhen GUAN
;
Haiyan WANG
Author Information
1. 南阳市中心医院中药药学部,河南南阳 473000
- Publication Type:Journal Article
- Keywords:
zhibitai capsules;
HPLC-QAMS;
chemometrics;
statistics software;
principal component analysis;
partial least squares discrimination analysis
- From:
Drug Standards of China
2024;25(6):545-554
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a method for the quality evaluation of zhibitai capsules by high performance liquid chromatography-quantitative analysis of multi-components by single marker(HPLC-QAMS)combined with chemometrics.Methods:HPLC method was used to establish the relative correction factors(f)of alisol A with vitexin-4"-O-glucoside,rhamnosylvitexin,oleanolic acid,ursolic acid,atractylenolide Ⅲ,atracylenolide Ⅰ,alisol A 24-acetate and 23-acetate alisol B by external standard method with alisol A as the internal reference.The estab-lished f was used to calculate the contents of the corresponding eight components,and the differences between the measured values and the calculated values were compared.The content data were analyzed by chemometrics to evaluate its quality.Results:The f values of alisol A with vitexin-4"-O-glucoside,rhamnosylvitexin,oleanolic acid,ursolic acid,atractylenolide Ⅲ,atracylenolide Ⅰ,alisol A 24-acetate and 23-acetate alisol B were 1.044 0,0.633 1,0.861 0,0.691 7,1.224 8,1.372 7,1.516 1 and 0.768 2,respectively,and the repeatability was good.Nine components in 13 batches of zhibitai capsules were determined by QAMS method and external standard method,and the results were not significantly different.The results of principal component analysis showed that 13 batches of samples were clustered into 3 categories.The main quality difference factors of zhibitai capsule were rhamnosylvitexin,ursolic acid,atractylenolide Ⅲ,atracylenolide Ⅰ and 23-acetyl alisol B.Conclusion:The estab-lished method can be used for the comprehensive evaluation of the quality of zhibitai capsules.