Ingredient Analysis

Multi-component determination and chemometric analysis of Xiaoru Sanjie capsules by HPLC*

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  • 1. NMPA Key Laboratory for Quality Evaluation of Gelatin Products,Shandong Provincial Institute for Food and Drug Control,Jinan 250101,China;
    2. Shandong Shenzhou Buchang Pharmaceutical,Co.,Ltd.,Heze 274000,China;
    3. Shandong University of Traditional Chinese Medicine,Jinan 250355,China;
    4. Shandong Academy of Chinese Medicine,Jinan 250014,China

Revised date: 2020-05-20

  Online published: 2024-07-15

Abstract

Objective: To establish a method for overall quality evaluation of Xiaoru Sanjie capsules by multi-component determination and chemometric analysis. Methods: Separation was performed on a Hypersil GOLD C18(250 mm×4.6 mm,5 μm)column. The mobile phase was acetonitrile-0.2% phosphoric acid at a flow rate of 1 mL·min-1 with gradient elution. The column temperature was 25 ℃ and the injection volume was 10 μL. The detection wavelength was set at 230 nm. Results: The six markers reached baseline separation,the linearity was good and the average recoveries were 100.0%,97.8%,99.7%,97.6%,97.4% and 100.3%,respectively with RSDs less than 2.0%. Precision,stability and reproducibility of the method were satisfactory. The contents of the above six components in 13 batches of sample were 2.592-4.509,0.582-0.978,2.343-3.743,2.373-4.743,0.522-1.049 and 2.949-3.928 mg·g-1,respectively.Chemometric analysis showed that there were some differences among the samples from different years. Significant characteristic peaks for discrimination of different samples were paeoniflorin,salvianolic acid B and paeonol.Conclusion: The method is accurate and specific,which can be used for the quality control of Xiaorusanjie capsules.

Cite this article

XU Li-li, LIN lin, YU Feng-rui, CUI Wei-liang, XU Xing-yan, WANG Minggeng, LIN Yu-mei, CUI Qiao-hong, LI Jun, LIN Yong-qiang, LIN Hui-bin . Multi-component determination and chemometric analysis of Xiaoru Sanjie capsules by HPLC*[J]. Chinese Journal of Pharmaceutical Analysis, 2021 , 41(4) : 594 -602 . DOI: 10.16155/j.0254-1793.2021.04.05

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