Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (2): 146-151.
DOI: 10.19803/j.1672-8629.20210474

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UPLC fingerprints of tripterygium glycosides tablets from different manufacturers

WANG Yadan1, YAN Jiangong1, CHEN Minghui1, PANG Yu2#, DAI Zhong1, MA Shuangcheng1*   

  1. 1National Institutes for Food and Drug Control, Beijing 102629, China;
    2Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China
  • Received:2021-05-08 Online:2023-02-15 Published:2023-02-17

Abstract: Objective To establish UPLC fingerprints of tripterygium glycoside tablets, and to evaluate the quality of preparations from different manufacturers by chemometrics. Methods Chromatographic separation was performed on the Waters Cortecs T3 column (2.1 mm × 100 mm, 1.6 μm). Acetonitrile-water was adopted as the mobile phase for gradient elution. The flow rate was 0.4 mL/min and the detection wavelength 220 nm. ChemPattern software was used for the establishment of the common pattern of fingerprints, similarity evaluation, and for principal component analysis and cluster analysis. At the same time, the common peaks were identified using the UPLC-QTOF-MS method. Results The UPLC fingerprints of 25 batches of tripterygium glycoside tablets from 9 manufacturers were established, and 51 common peaks were determined. Among them, 23 were identified, and most of them were found to be alkaloids. The similarity of the tested samples ranged from 0.18 to 0.99, suggesting that the quality of the samples from different manufacturers and even that of samples of different batches from the same manufacturer varied greatly. Principal component analysis and cluster analysis divided the nine manufacturers’ preparations into three categories and screened out three main different components. Conclusion UPLC fingerprints can reflect the variations in tripterygium glycoside tablets from various manufacturers, which can provide reference for quality evaluation of the preparations based on chemometrics.

Key words: tripterygium glycoside tablets, UPLC fingerprints, similarity, principal component analysis, cluster analysis, quality evaluation

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