摘要
目的:建立泽兰配方颗粒的HPLC指纹图谱测定方法,并同时对咖啡酸、迷迭香酸的含量进行测定,为泽兰配方颗粒的质量评价提供依据。方法:采用HPLC法,色谱柱为C18,以乙腈-0.1%磷酸为流动相进行梯度洗脱,检测波长为325 nm,流速为1.0 mL/min,测定了10批泽兰配方颗粒。结果:指纹图谱检测结果中共呈现7个特征峰。含量测定结果表明,咖啡酸、迷迭香酸分别在0.001~0.205 4μg、0.005 2~1.030 4μg范围内的线性关系良好,r=1,两种成分平均回收率分别为99.2%、104.23%,RSD分别为1.23%、1.45%。结论:建立了同步测定泽兰配方颗粒指纹图谱与咖啡酸、迷迭香酸含量的方法,方法操作简便,准确,重现性好,可用于泽兰配方颗粒的质量研究和评价。
Objective: To establisha the fingerprint of Zelan Granules by HPLC, and to determine the contents of caffeic acid and rosmarinic acid, thus to provide evidence for the quality evaluation of Zelan Granules. Methods: The chromatography column of C18 was applied, the mobile phase consisted of acetonitrile and 0.1% phosphoric acid with the gradient mode at a flow rate of 1 mL/min, the wavelength was set at 325 nm. Ten batches of Zelan Granules were measured. Results: The fingerprint showed seven characteristic peaks. The content determination showed that the linear relationship of caffeic acid and rosmarinic acid were good(r=1), which were at 0.001 0~0.205 4 μg and 0.005 2~1.030 4 μg respectively, the average recovery rates were 99.20% and 104.23%, and RSD were 1.23% and 1.45%. Conclusion: A method for simultaneous determination of the fingerprint and the contents of caffeic acid and rosmarinic acid in Zelan Granules were established. The method is accurate, stable and credible. It can be used for the quality study and evaluation of Zelan Granules.
引文
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