高效液相色谱法测定胞磷胆碱钠注射液中的有关物质

Determination of Related Substances of Citicoline Sodium Injection by High Performance Liquid Chromatography

目的建立胞磷胆碱钠注射液中有关物质的高效液相色谱测定方法。方法采用C18柱(250 mm×4.6 mm,5μm),以磷酸盐缓冲液(0.1 mol/L磷酸二氢钾与0.01 mol/L四丁基氢氧化铵等量混合,用磷酸调节pH值至5.2)-甲醇(96∶4)为流动相,流速:0.8 ml/min,检测波长:276 nm,柱温:30℃。结果经破坏性试验后的胞磷胆碱钠注射液中各有关物质与胞磷胆碱分离良好;最低检测限为0.006 ng。结论该方法简便、专属性及灵敏度好,可用于胞磷胆碱钠注射液中有关物质的检查。

Objective To establish an high performance liquid chromatography method for the determination of related substances of citicoline sodium injection. Methods Seperation was performed on a ClS column （250 mm×4.6 mm,5μm）and the mobile phase was phosphate buffer [ potassium dihydrogen phosphate solution （0.1 mol/L） was mixed with the same amount of tetrabutylammonium hydroxide solution （0.01 tooL/L） ,with the pH value of the mixture adjusted to 5.2 by phosphate] -methanol （96： 4） at a folw rate of 0.8 m]/min. The column temperature was set at 30℃ and the detection wavelength was 276 nm. Results A good separation was achieved for citicoline sodium and its related substances. The limit of detection was 0.006 ng. Conclusion The method is simple, specific, sensitive and applicable to the determination of related substances of citicoline sodium injection.