HPLC法测定依达拉奉及其有关物质的含量

Determination of Edaravone and the Decomposed Production by HPLC

目的 建立依达拉奉及其相关物质及含量测定方法。方法 HPLC法 ,采用Shim -packC18色谱柱 ,以 0 .0 5mol·L-1磷酸二氢钾溶液 (pH4 .5 ) -乙腈 (70∶30 )为流动相 ,检测波长为 2 4 3nm。结果 依达拉奉在 6～ 4 8μg·ml-1范围呈良好的线性关系 ,r=0 .9999,重复性试验 RSD 为 0 .6 % (n =6 ) ,平均加样回收率为 99.74 % (RSD =0 .5 7% )。结论 该法简单、准确 。

Aim To establish an HPLC method for determination of edaravone and its related substances.Methods The separation was performed on a Shim-pack C 18 column,using 0.05mol·L -1 potassium dihydrogen phosphate(pH4.5)-acetonitrile(70∶30)as the mobile phase.The detection wavelength was 243nm.Results The method showed good linearity (r=0.999 9) in the range of 6～48μg·ml -1 and less variation(RSD=0.6%,n=6).The average recovery of edaravone was 99.74% (RSD=0.57%).Conclusion This method is simple and accurate,and suitable for the quality control of edaravone.