HPLC法测定奥拉西坦原料药中的有关物质

Determination of the Related Substances of Oxiracetam Raw Material by HPLC

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（pH3．0），流速为0．8ml／min，检测波长为214am。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0．2104～0．6312μg/ml（r=0．9997，n=5），检测限为0．95ng。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 oxiracetam raw material. METHODS： HPLC method was adopted. The determination was performed on Welch XB-C18 column with 0.01 mol/L potassium dihydrogen phosphate （pH ad- justed to 3.0） as mobile phase at the flow rate of 0.8 ml/min. The detection wavelength was set at 214 nm. RESULTS： At the select- ed chromatographic conditions, the prominent peak and the neighbor subsidiary peak could be well separated; the linear range of oxiracetam was 0.210 4-0.631 2 μg/ml （r=0.999 7, n=5）, with the detection limit of 0.95 ng. CONCLUSIONS： The method is accurate, convenient, specific, sensitive and suitable for the quality control of oxiracetam raw material.