高效液相色谱法测定奥拉西坦口服液中奥拉西坦的含量

HPLC determination of oxiracetam in oxiracetam oral solution

目的建立专属性强的HPLC法测定奥拉西坦口服液中奥拉西坦的含量。方法采用以氰基键合硅胶为填充剂(大连依利特,4.6mm×250mm,5μm)的色谱柱,以甲醇-水(2∶3)作为流动相,检测波长为214nm,流速为0.5mL·min-1。结果本色谱条件能将奥拉西坦与其他降解产物有效分离;奥拉西坦浓度在0.40～4.01μg线性关系良好;平均回收率为99.62%,RSD为0.41%(n=9)。结论本法专属性强、准确、简便,可用于奥拉西坦的质量控制。

Objective To establish an HPLC method to determine oxiracetam oral solution.Methods The Hypersil DBS CN（4.6 mm×250 mm,55 μm）column was used,and the mobile phase was Methanol-water（2∶3）,the detection wavelength was 214 nm,and the flow rate was 0.5 mL·min^-1.Results The calibration curve was linear at 0.40～4.01 μg.The average recovery was 99.62% and RSD was 0.41%.Conclusion This method is specific,accurate and simple,and can be used for the quality control of oxiracetam.