Quality Control

Quality evaluation of Yupingfeng pills based on HPLC fingerprint and determination of multi-index components and chemometrics analysis

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  • Zhejiang Institute for Food ang Durg Control, NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine(Traditional Chinese Patent Medicine), Key Laboratory of Functional Food Nutrition and Quality Safety for State Market Regulation, Key Laboratory of Health Food Quality Safety of Provincial Market Regulation, Hangzhou 310052, China

Received date: 2022-08-16

  Online published: 2024-06-25

Abstract

Objective: To establish a quality evaluation method of Yupingfeng pills based on HPLC fingerprints, quantitative analysis of multi-components and chemometrics analysis. Methods: The chromatographic column was Agilent Zorbax C18 column (150 mm×4.6 mm, 5 μm) and the column temperature was set at 40 ℃. The detection wavelengthes were set at 220, 275, and 300 nm. The mobile phase was composed of acetonitrile-water in gradient elution manner at a flow rate of 1.2 mL·min-1. The HPLC fingerprint of Yupingfeng pills was established, the common peaks were determined by similarity evaluation system for chromatographic fingerprint of TCM (Version 2012), and the similarity was calculated. The content determination methods for prim-O-glucosylcimifugin, calycosin-7-O-β-D-glucoside, cimifugin, 5-O-methylvisammioside, calycosin, sec-O-glucosylhamaudol, quercetin, formononetin, atractylodes lactone Ⅲ, atractylodes lactone Ⅱ, atractylodes lactoneⅠand atractylone were validated. The chemometrics methods such as cluster analysis and principal component analysis were used to evaluate the quality of Yupingfeng pills between different batches based on the results of fingerprint common peaks’ area. Results: The fingerprint of Yupingfeng pills was established and 23 common peaks were identified, 12 chemical components were identified, the similarities were above 0.95. 12 components had good linear relationships in the range of mass concentration (r≥0.999 7), and the average recoveries were 95.7%-103.2% with the RSDs (n=9)<3.6%. The results of cluster analysis showed that 10 batches of Yupingfeng pills were clustered into two groups when distance was 15. The results of principal component analysis extracted 3 principal components, 6 main factors (sec-O-glucosylhamaudol, prim-O-glucosylcimifugin, calycosin-7-O-β-D-glucoside, 5-O-methylvisammioside, atractylodes lactone Ⅲ, calycosin) affected the quality between different batches of Yupingfeng pills. Conclusion: The method is simple, accurate and reproducible, and can been used for the quality control and evaluation of Yupingfeng pills.

Cite this article

YUE Chao, XU Pu, ZHANG Wen-ting, ZHAO Chao-qun, TAO Rui, HE Xiao-ying, ZHAO Jing-kai, WANG Feng . Quality evaluation of Yupingfeng pills based on HPLC fingerprint and determination of multi-index components and chemometrics analysis[J]. Chinese Journal of Pharmaceutical Analysis, 2022 , 42(11) : 2019 -2028 . DOI: 10.16155/j.0254-1793.2022.11.19

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