HPLC法同时测定理气活血滴丸中阿魏酸和藁本内酯含量研究

Simultaneous determination of ferulic acid and ligustilide in Liqihuoxue Dripping Pills by HPLC

目的分析高效液相色谱(HPLC)法同时测定理气活血滴丸中阿魏酸和藁本内酯含量的可行性和适用性,为其质量控制提供实验基础。方法称取理气活血滴丸制备供试品溶液,称取阿魏酸和藁本内酯制备对照品溶液,按处方比例及工艺制备缺川芎的阴性样品溶液,进行专属性、线性关系、精密度、重复性及稳定性实验分析。结果在与阿魏酸、藁本内酯对照品色谱图相应的保留时间处,供试品溶液色谱图中有阿魏酸、藁本内酯的吸收峰,阴性样品溶液中未显示对应的色谱峰。阿魏酸和藁本内酯浓度分别为2.84～45.45、32.70～523.25μg/mL时有良好的线性关系,二者平均加样回收率分别为103.79%[相对标准偏差(RSD)=1.43%]、94.75%(RSD=1.78%)。该方法精密度、重复性良好及12h内稳定性良好。结论 HPLC法可同时测定理气活血滴丸中阿魏酸和藁本内酯的含量,具有操作简单、快速准确的特点,能为进一步规范其质量控制提供实验基础。

Objective To analyse the feasibility and applicability of simultaneous determination of ferulic acid and ligustilide in Liqihuoxue Dropping Pills by high performance liquid chromatography(HPLC),and to provide experimental basis for quality control of Liqihuoxue Dropping Pills. Methods Liqihuoxue Dropping Pills were weighed to prepare the test solution,ferulic acid and ligustilide were weighed to prepare the reference solution,and the negative sample solution of Ligusticum Chuanxiong was prepared according to the prescription proportion and technology.The specificity,linear relationship,precision,repeatability and stability were analyzed by experiments. Results At the retention time corresponding to the reference chromatograms of ferulic acid and ligustilide,the absorption peaks of ferulic acid and ligustilide were found in the sample solution chromatogram,but no corresponding peaks were found in the negative sample solution.Ferulic acid and ligustilide had good linear relationship in the concentration range of 2.84-45.45,32.70-523.25 μg/mL respectively.The average recovery of the two methods were 103.79%( RSD =1.43%) and 94.75%( RSD =1.78%).The method had good precision,repeatability and stability in 12 hours. Conclusion The content of ferulic acid and ligustilide in Liqihuoxue Dropping Pills can be simultaneously determined by HPLC,which is simple,rapid and accurate,and can provide experimental basis for further standardizing the quality control of Liqihuoxue Dropping Pills.