HPLC法测定不同厂家补中益气丸中阿魏酸和异阿魏酸的含量

Determination of ferulic acid and isoferulic acid in Buzhongyiqi pill by HPLC

目的建立补中益气丸中阿魏酸、异阿魏酸的含量测定,确定阿魏酸、异阿魏酸含量范围。方法采用反相高效液相色谱法测定,色谱柱为Sunfire ODS C18柱（4.6 mm×150 mm,5μm）,流动相采用乙腈：0.05%磷酸的梯度洗脱,柱温为30℃;检测波长为324 nm。结果方法精密度、重复性、稳定性RSD值均小于3%,阿魏酸、异阿魏酸平均加样回收率分别为97.93%,RSD为2.81%、100.37%,RSD为2.72%。11个厂家53批样品中阿魏酸、异阿魏酸含量分别在0.0467－0.1718 mg·g^-1、0.0289-0.7350 mg·g^-1范围。结论方法准确、可靠,为制剂标准含量范围制定提供参考。

Aim To establish an HPLC method for the determination of ferulic acid and isoferulic acid in Buzhongyiqi pill.Method Sunfire ODS C18（4.6 mm×150 mm,5 μm）was used.The mobile phase consisted of 0.05%phosphoric acid and acetonitrile with gradient elution,the column temperature at 30℃.The ultraviolet wavelength was set at 324 nm.Results Relationship among the concentrations and the peak areas of ferulic acid and isoferulic acid were linear respectively.The RSD of precision,stability,repeatability and recovery were all less than 3%.The content of ferulic acid and isoferulic acid was very different among 53 bates Buzhongyiqi pill.The content of ferulic acid is between 0.0467 and 0.1718 mg·g^-1,whith that of isoferulic acid is between 0.0289 and 0.7350 mg·g^-1.Conclusion This method is reliable and accurate,which can be used for the quality control of Buzhongyiqi pill.