高效液相色谱法测定注射用兰索拉唑中兰索拉唑的含量

Determination of related substances in lansoprazole for injection by high performance liquid chromatography

目的采用高效液相色谱法建立测定兰索拉唑及其制剂注射用兰索拉唑含量的方法。方法色谱柱为Diamonsil C18（4.6mm×250mm,5μm）;流动相为甲醇∶水（70∶30）;检测波长为285nm;流速1.0mL/min;柱温25℃;进样量20μL。结果注射用兰索拉唑制剂中的辅料对兰索拉唑的测定无干扰,兰索拉唑在50~500mg/L浓度范围内与峰面积呈良好的线性关系,精密度[相对标准差（relative standard deviation,RSD）=0.14%]良好;低、中、高3种浓度平均回收率分别为100.0%、98.3%、101.7%,RSD分别为0.5%、0.3%、0.4%。结论该方法简便、准确、专属性好,可用于兰索拉唑及其制剂含量的测定。

Objective To use high performance liquid chromatography for the determination of the content of lansoprazole and lansoprazole injection. Methods The determination was carried out on with a Dikma Diamonsil TM2C18（4.6mm×250mm,5μm）column.The mobile phase was methanol-water（70∶30）.The determination wavelength was 285 nm.Results The excipients did not interfere with the determination of lansoprazole.The developed method could be used for the determination of lansoprazole and its injection.The calibration curve of lansoprazole was in good linearity over the range of 50-500mg/L.The precision of the method（relative standard deviation[RSD]=0.14%）was good.The average recovery of the low,medium,and high concentrations were 100.0%,98.3%,101.7% with RSD 0.5%,0.3%,0.4%respectively.Conclusion The method is simple,accurate and specific.It can be used for the determination of lansoprazole.