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目的:建立测定奥拉西坦原料药有关物质的方法。方法:采用高效液相色谱法。色谱柱为月旭XB-C18,流动相为0.01mol/L磷酸二氢钾溶液(pH 3.0),流速为0.8 ml/min,检测波长为214 nm。结果:在选定的色谱条件下,主峰和相邻杂质峰能较好地分离;奥拉西坦检测质量浓度线性范围为0.210 4~0.631 2μg/m(lr=0.999 7,n=5),检测限为0.95 ng。结论:本方法准确、简便,专属性强,灵敏度高,可用于奥拉西坦原料药的质量控制。
Objective: To establish a method for the determination of related substances of oxiracetam drug substance. Methods: Using high performance liquid chromatography. The column was Yuexu XB-C18 with a mobile phase of 0.01 mol / L potassium dihydrogen phosphate solution (pH 3.0) at a flow rate of 0.8 ml / min and a detection wavelength of 214 nm. Results: Under the selected chromatographic conditions, the peak of the main peak and adjacent impurity peaks could be separated well. The linear range of the quality of oxiracetam was 0.210 4 ~ 0.631 2μg / m (lr = 0.999 7, n = 5) The detection limit is 0.95 ng. Conclusion: The method is accurate, simple, specific, sensitive and can be used for the quality control of oxiracetam APIs.