藿香正气水UPLC指纹图谱及相关性研究

Research on UPLC Fingerprint and Correlation of Huoxiang Zhengqi Liquid

目的:建立藿香正气水超高效液相色谱(UPLC)指纹图谱,为其质量评价提供依据。方法:采用UPLC,色谱柱为Waters Acquity BEH-C_(18)柱(2.1 mm×150 mm,1.7μm),流动相为乙腈-0.1%磷酸溶液,梯度洗脱,流速:0.3 ml·min^(-1),检测波长:280 nm。建立藿香正气水的UPLC指纹图谱,并采用中药色谱指纹图谱相似度评价软件(2012.1版)进行相似度评价。结果:建立了藿香正气水UPLC指纹图谱,并标定了9个特征峰,通过对照药材和对照品比对法确定了特征峰的归属。30批藿香正气水相似度为0.704~0.971,聚类分析显示,能有效区分不同厂家之间的图谱差异。结论:UPLC指纹图谱测定方法操作简便,结果准确、稳定,能为藿香正气水制剂质量控制,以及各厂家之间一致性评价提供参考依据。

Objective:To establish the fingerprint of Huoxiang Zhengqi liquid by ultra performance liquid chromatography(UPLC)and provide basis for its quality evaluation.Methods:A UPLC was used and the chromatographic column was a Waters Acquity BEH-C_(18) column(2.1 mm×150 mm,1.7μm).The mobile phase was acetonitrile-0.1%phosphoric acid solution with gradient elution at a flow rate of 0.3 ml·min^(-1),and the detection wavelength was 280 nm.The UPLC fingerprint of Huoxiang Zhengqi liquid was established,and the similarity evaluation software of chromatographic fingerprint of Chinese medicine(2012.1)was used for similarity evaluation.Results:The UPLC fingerprint of Huoxiang Zhengqi liquid was established,and 9 characteristic peaks were calibrated.The attribution of characteristic peaks was determined by the comparison method between reference materials and reference substances.The similarities of 30 batches of Huoxiang Zhengqi liquid were 0.704-0.971.Cluster analysis showed that it could effectively distinguish the map differences among different manufacturers.Conclusion:The UPLC fingerprint method is simple,accurate and stable.It can provide reference for the quality control of Huoxiang Zhengqi liquid and the consistency evaluation among manufacturers.