Ingredient Analysis

HPLC fingerprint of substance benchmarks in Gualou Guizhi decoction and quantity transfer rule of key quality attributes*

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  • 1. School of Pharmacy, Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China;
    2. Department of Pharmacy, The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou 350003, China

Received date: 2023-10-28

  Online published: 2024-08-05

Abstract

Objective: To establish a fingerprint of Gualou Guizhi decoction and a method for determination of multi-component to clarify the transfer rule of quantities and quality from decoction pieces and substance benchmarks. Methods: Fifteen batches of Gualou Guizhi decoction substance benchmarks were prepared and analyzed by the method of HPLC. Traditional Chinese medicine (TCM) Chromatographic Fingerprint Similarity Evaluation Software (2012) and hierarchical cluster analysis (HCA), principal component analysis (PCA) and orthogonal partial least squares-discriminant analysis (OPLS-DA) was used to evaluate the quality differences between batches of substance benchmarks, and screen the main chemical compositions that were led to quality discrepancy. The main differential components were determined by HPLC. And their contents, yields and transfer rates were analyzed for transfer rule of quantities and quality. Results: HPLC fingerprint of Gualou Guizhi decoction was established. A total of 30 common peaks in the fingerprint of Gualou Guizhi decoction substance benchmarks were assigned. Compared with the reference standards, 9 components were identified as gallic acid, albiflorin, paeoniflorin, liquiritin, ononin, liquiritigenin, cinnamic acid, isoliquiritigenin and glycyrrhizic acid. The similarities of 15 batches of Gualou Guizhi decoction substance benchmarks samples were all above 0.920. All of them were divided into two categories by three chemical recognition modes for 5 major differential components, including glycyrrhizic acid, liquiritigenin, paeoniflorin, iquiritin, and ononin. The HPLC was also applied to determine the contents of multi-components and the method validation results were good. The average transfer rates of five index components were 51.65%, 40.46%, 74.74%, 60.06%, and 34.54%, respectively and their average extraction rate was 14.20%. Conclusion: The critical quality properties of Gualou Guizhi decoction can be stably transferred from decoction pieces to substance benchmarks. The method of fingerprint and content determination is accurate and reliable, which is able to provide technique for quality control of Gualou Guizhi decoction formulation.

Cite this article

LIU Ke, LÜ Gui-jie, WANG Xi-lin, XIE Yu-he, XU Wen, YANG Yi, ZHANG Xun, LIN Yu . HPLC fingerprint of substance benchmarks in Gualou Guizhi decoction and quantity transfer rule of key quality attributes*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44(7) : 1125 -1136 . DOI: 10.16155/j.0254-1793.2023-0694

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