注射用兰索拉唑有关物质分析方法的建立

Establishment of the Analysis Method for Determining the Related Substance in Lansoprazole for Injection

目的:建立有效测定注射用兰索拉唑中有关物质含量的方法。方法:流动相为乙腈-水-三乙胺(40∶60∶1,用磷酸溶液调节p H值至6.2);检测波长285nm,柱温25℃,流速1.0ml/min,进样量20μl。结果:兰索拉唑与杂质B分离完全,溶剂、辅料对有关物质测定无干扰,方法专属性、回收率、精密度、耐用性均良好。结论:该方法专属性好、重现性好,适用于注射用兰索拉唑中有关物质的测定。

Objective： To establish an efficacious method for determining the content of related substance in lansoprazole for iniection. Methods： The mobile phase is acetonitrile-water-triethylamine（40：60：1,adjucting the pH to 6.2 by phosphoric）; The determination wavelength was 285nm and the column temperature is 25 ℃ with 1.0ml/min flow rate and 20 μl injection volumn. Results：The impurity B can be absolutely separated with Lansoprazole and there＇s no interference from the solution and excipients. The method has good specificity,accuracy, precision and durability. Conclusion： The method has good specificity and repeatability which is suitable for the determination of the related substance in Lansoprazole for injection.