CHINESE JOURNAL OF MEDICINAL GUIDE ›› 2026, Vol. 28 ›› Issue (2): 220-220-227.doi: 10.1009-0959.2026.030008

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Research on UHPLC Fingerprint and Multi-Component Quantification of Siyu Baotai Formula Powder

WANG Xinlan1，2， YE Xiao2， ZHANG Jianing2， WANG Yu2， HUANG Shujia2， WEN Nie2， #br# CAO Xinyao3， YANG Shuo3， SUN Lu1， LI Muzi3*， LIU Ying1，4*   

  1. 1.School of Pharmacy， Shenyang Pharmaceutical University， Liaoning Shenyang 110016， China；
    2.Institute for Safety Evaluation， National Institutes for Food and Drug Control， Beijing Key Laboratory for
    Safety Evaluation of Drugs， Beijing 100176， China；
    3.Scientific Research Institute， Beijing Tongrentang Co.， Ltd.， Beijing 100079， China；
    4.Institute for Chemical Drug Control， National Institutes for Food and Drug Control， Beijing 102629， China
  • Received:2025-09-04 Revised:2025-11-25 Accepted:2026-03-18 Online:2026-02-28 Published:2026-03-19

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Abstract:

Objective： To establish the ultra-high performance liquid chromatography （UHPLC） fingerprint chromatography of Siyu Baotai formula powder and the method for simultaneous determination of the contents of 7 components in the Siyu Baotai formula powder， providing a reference for the quality control of Siyu Baotai formula powder and the subsequent development of its dosage forms.Methods： The chromatography was performed on Waters Acquity UPLC® BEH C8 column （2.1 mm × 100 mm， 1.7 µm）， and gradient elution with acetonitrile-0.1% trifluoroacetic acid （TFA） aqueous solution as the mobile phase at the flow rate of 0.4 mL·min-1. The column temperature was 30 ℃ and the detection wavelength was set at 230 nm.Results： By analyzing three batches of samples produced on a large scale by the pharmaceutical factory， the UHPLC fingerprints of Siyu Baotai formula powder were established. There were 24 common peaks in the UHPLC fingerprints， from which 9 compounds were identified. The method demonstrated good precision， repeatability and stability. The similarity evaluation results showed that the similarity of three batches of Siyu Baotai formula powder is all greater than 0.990. The standard curves of the components showed a good linearity （R2 ≥ 0.999 6）， with average recoveries ranging from 96.2% to 107.3%， and the RSD of the recovery rates were ≤ 3.81%. The mean content of paeoniflorin， hyperoside， ferulic acid， liquiritin， naringin，neohesperidin and magnolol in three different batches of Siyu Baotai formula powder were 1 451.217， 291.033， 169.033， 263.700， 4 197.467， 2 381.300， 269.950 µg·g-1 respectively.Conclusion： In this study， the fingerprint and multi-component content determination method for Siyu Baotai formula powder were established for the first time. The methodological validation demonstrated that this method is rapid， simple to operate and has good reproducibility. It can provide a scientific basis for the quality evaluation of the Siyu Baotai formula powder and the optimization of its related dosage forms.

 

Key words: Siyu Baotai formula； , Powder； , Chromatographic fingerprint； , Multi-component quantification； , Quality research

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