HPLC测定注射用兰索拉唑中兰索拉唑的含量

目的：研究注射用兰索拉唑制剂工艺，并采用高效液相色谱法建立其含量测定方法。方法：制备注射用兰索拉唑， AlltimaTM C18柱（4.6mm×250mm，5μm）；乙腈-水-三乙胺（40∶60∶1）（用磷酸调节pH值至7.0）为流动相；检测波长为285 nm。结果：制剂中辅料对主药测定无干扰，兰索拉唑在32.16～75.04μg/mL浓度范围内，峰面积与浓度呈良好的线性关系；精密度（RSD＝0.20%）良好；平均回收率为99.4%，RSD＝0.94%（n＝9）。结论：本方法简便、迅速、准确、专属性强，可用于注射用兰索拉唑的含量测定。

Determination of lansoprazole injection by HPLC

Objective：To prepare lansoprazole for injection and establish a HPLC method for determing the content of lansoprazole in lansoprazole for injection. Methods： A AlltimaTM C18 column （4.6mm＆#215;250mm, 5μm） was used. The mobile phase was acetonitrile-water-triethylamine （40：60：1, adjusted to pH=7.0 with phosphoric acid）. The determination wavelength was 285nm. Results：The excipients did not interfere with the determination of lansoprazole. The linear range of lansoprazole was 32.16~75.04μg＆#183;m-1. The precision of the method （RSD=0.20%） was good. The average recovery was 99.4%, and RSD was 0.94%（n=9）. Conclusion：The method is simple, speedy, accurate and specific for the quantitation of lansoprazole.