摘要
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.
出处
《中国药房》
CAS
CSCD
2014年第1期66-68,共3页
China Pharmacy