回药扎里奴思方UPLC指纹图谱结合多成分含量测定的质控方法研究

Study on Quality Control Method of Zhali Nusi Fang by UPLC Fingerprint and Multi-Components Quantitative Analysis

    摘要
  • 摘要: 目的   建立扎里奴思方的UPLC-PDA指纹图谱及多成分含量测定方法。方法   采用Waters ACQUITY UHPLC T3(2.1 mm×100 mm，1.7 μm)色谱柱，流动相为乙腈(A)-0.1%甲酸水溶液(B)，梯度洗脱，流速0.4 mL/min，柱温30 ℃，检测波长317 nm；采用UPLC-PDA对其中9种物质进行含量测定。结果   共确定扎里奴思方指纹图谱13个共有色谱峰，通过对照品比对出其中9个共有峰。10批样品指纹图谱相似度为0.923~0.983。9种物质在一定浓度范围内呈良好线性关系，r值均大于0.999 0；含量测定结果表明肉桂酸、没食子酸含量较高。各物质回收率在98.82%~102.91%之间，RSD均小于2.52%；样品在24 h内稳定，重复性良好。结论   建立了扎里奴思方指纹图谱分析方法及含量测定方法，该方法简便、重复性良好，可为进一步完善扎里奴思方质量控制方法提供参考。

     

    Abstract: OBJECTIVE   To establish the UPLC-PDA fingerprint analysis and multi-components content determination methods of Zhali Nusi Fang.METHODS   A Waters ACQUITY UHPLC T3 (2.1 mm × 100 mm, 1.7 μm) column was used with a gradient elution. The mobile phase was acetonitrile (A)-0.1% formic acid aqueous solution (B), flow rate was 0.4 mL/min, column temperature was 30 ℃, detection wavelength was 317 nm; nine chemical components were determined by UPLC-PDA.RESULTS   13 common peaks were found in the fingerprint of Zhali Nusi Fang and 9 peaks were identified by standard substances. The similarity of fingerprints of 10 batches was between 0.923 and 0.983. The linear relationship of 9 components was good in certain concentration range, and the r value was greater than 0.999 0. The results showed that the contents of cinnamic acid and gallic acid were high. The recoveries ranged from 98.82% to 102.91%, RSD was less than 2.52%. The samples were stable within 24 hours with good repeatability.CONCLUSION   The fingerprint analysis method and content determination method of Zhali Nusi Fang are established. The method is simple and repeatable, which can provide reference for further elucidation of the basic research of pharmacodynamic substances and quality control.

     

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