高效液相色谱法测定奥扎格雷钠注射液中有关物质

Determination of related substances in ozagrel sodium injection by HPLC

目的建立高效液相色谱法测定奥扎格雷钠注射液中有关物质的方法。方法选用C18柱;以0.01mol/L磷酸二氢钾溶液-甲醇(75:25)(用氢氧化钠溶液调节pH6.0)为流动相;波长:272nm;流速:1.0ml/min;进样量:20μl;柱温:25℃。结果空白辅料无干扰,降解产物与主成分峰都能完全分离;检测限约为0.3ng,定量限约为1.0ng。结论该测定方法简便、快速、可靠,可用于奥扎格雷钠注射液中有关物质的测定。

Objective To establish a high performance liquid chromatography （HPLC） method for determining related substances in ozagrel sodium injection. Methods The related substances were determined by HPLC. The HPLC system consisted of C18 column, 0.01mol/L potassium dihydrogen phosphate buffer-methanol （75 ; 25 ） （adjusted to pH 6.0 with sodium hydroxide solution） as the mobile phase, the column temperature at 25℃, the flow rate of mobile phase 1.0 ml/min, the wavelength of detector at 272 nm and the injection volume 20 μl. Results Additives did not interfere with the quantitation of related substances in ozagrel sodium injection, and the principal peak was thoroughly separated with the degradation product peak. The detection limit was about 0.3 ng, and the quantitation limit was about 1.0 ng. Conclusion The method is simple, rapid and suitable. It can be used to determine related substances in ozagrel sodium injection.