HPLC法测定依达拉奉注射液中的有关物质

Determination of related substance in Edaravone Injection by HPLC

目的建立高效液相色谱法测定依达拉奉注射液的有关物质。方法采用Agilent SB-C_(18)(4.6 mm×250 mm,5μm)色谱柱,流动相A为0.05 mol·L^(-1)磷酸二氢钾溶液(用三乙胺调节pH值至7.0),流动相B为甲醇,梯度洗脱,流速为1.0 mL·min^(-1),检测波长为243 nm,柱温30℃。结果依达拉奉及各杂质均能有效分离,在相应的浓度范围峰面积与浓度呈良好的线性关系,相关系数均大于0.999,平均回收率在95%～105%范围内。结论该方法专属性强,简便可靠、灵敏、准确,适用于依达拉奉注射液中的有关物质的测定。

Objective To establish an HPLC method for the determination of related substance in Edaravone Injection. Methods The analysis was performed on an Agilent SB-C 18 column(4.6 mm×250 mm,5 μm) with gradient elution and the mobile phase A was 0.05 mol·L^-1 potassium dihydrogen phosphate (adjust pH to 7.0 by triethylamine),the mobile phase B was methanol and the flow rate was 1.0 mL·min-1.The detection wavelength was 243 nm,and the column temperature was 30 ℃. Results Under the described chromatographic condition,the known impurities and the unknown impurities were successfully separated from each other.The correlation coefficient of impurities were all greater than 0.999 and the recoveries were between 95% and 105%. Conclusion The method was specific,simple and accurate and suitable for the determination of the related substances in Edaravone Injection.