院内制剂夏膝颗粒中迷迭香酸含量的HPLC测定

Content determination of rosmarinic acid in Xiaxi Granules by HPLC

目的建立夏膝颗粒迷迭香酸的含量测定方法,为质量控制提供实验依据。方法以十八烷基硅烷键合硅胶为填充剂的色谱柱;以甲醇-0.1%三氟乙酸(40:60)为流动相;检测波长330 nm。结果迷迭香酸峰面积和质量浓度之间线性关系良好,r为1.0000,精密度、稳定性均符合要求,平均加样回收率为97.72%,RSD为1.47%。结论本试验研究并建立了HPLC迷迭香酸的含量测定方法,可以作为夏膝颗粒质量控制的依据。

Objective To establish a method for determining the content of rosmarinic acid in Xiaxi Granules and provide an experimental reference for its quality control.Methods The chromatographic separation was performed on a chromatographic column with octadecyl silane bonded silica gels as filling agents,with methanol-0.1%trifluoroacetic acid(40:60)as the mobile phase and with a detection wavelength of 330 nm.Results There is a good linear relationship between the peak area of rosmarinic acid and its mass concentration(r=1.0000).Its precision and stability were in line with the requirements.Its average sample recovery rate was 97.72%,and its RSD was 1.47%.Conclusion A HPLC method for the determination of rosmarinic acid is established in the experiment,which can be used as a reference for the quality control of Xiaxi Granules.