苯基柱法测定注射用泮托拉唑钠的有关物质

Determination of Related Substances in Pantoprazole Sodium for Injection by Phenyl Column Method

目的建立测定注射用泮托拉唑钠中有关物质的方法。方法采用高效液相色谱法,色谱柱为Hypersil GOLD Phenyl,以水为流动相A,以甲醇为流动相B,采用梯度洗脱,流速1.0 mL·min^(-1),检测波长为290 nm,柱温30℃,进样体积20μL。结果该色谱条件下,杂质D与杂质F分离度良好。结论该方法简便、灵敏度高,能有效地测定注射用泮托拉唑钠的有关物质。

OBJECTIVE To establish a method for the determination of related substances in Pantoprazole sodium for injections.METHODS HPLC method was adopted.The determination was performed on Hypersil GOLD Phenyl column with mobile phases consisted of water-methanol.The flow rate was 1.0 mL·min^(-1).The detection wavelength was set at 290 nm,and the column temperature was 30℃,and injection volume was 20μL.RESULTS Under this condition,the impurity D could be completely separated from impurity F.CONCLUSION The method is simple,sensitive and suitable for the determination of related substances in Pantoprazole sodium for injections.