Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (9): 982-986.
DOI: 10.19803/j.1672-8629.2022.09.11

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Determination of 5 saponins in Xuesaitong injection by quantitative analysis of multi-components by single marker

WANG Bing1, LI Dongmei1,Δ, WANG Changshun2, FENG Yanan1, LIU Yongli2,*   

  1. 1Hebei Pharmacovigilance Center, Shijiazhuang Hebei 050090,China;
    2Hebei Institute for Drug and Medical Device Control, Shijiazhuang Hebei 050090,China
  • Received:2022-05-24 Online:2022-09-15 Published:2022-09-16

Abstract: Objective To establish a method for simultaneous assay of 5 kinds of saponins in Xuesaitong injection by quantitative analysis of multi-components by single marker (QAMS),and to investigate the factors influencing the correction factors. Methods Ultra high performance liquid chromatography(UPLC)was used,the determination was performed on Waters HSS T3 (2.1 mm×100 mm, 1.7 µm) column with mobile phase consisted of acetonitrile and water gradient elution. The detection wavelength was set at 203nm. Ginsenoside Rg1 was used as control to establish the relative correction factors(RCF)with panax notoginseng R1, ginsenoside Re, Rb1 and Rd. The contents of notoginseng saponin R1, ginsenoside Re, Rb1 and Rd were calculated by using the correction factor, and the contents of these four components were determined by external standard method. The difference between them was compared to verify the accuracy and scientificity of the method. Results There was no obvious difference between the content value calculated by correction factor and the measured value by external standard method. Conclusion It is feasible and accurate to control the quality of Xuesaitong injection with one test and multiple evaluation.

Key words: quantitative analysis of multi-components by single marker (QAMS), Xuesaitong, injection, relative correction factor (RCF), UPLC, saponins

CLC Number: