HPLC测定注射用兰索拉唑中兰索拉唑的含量和有关物质

 目的采用高效液相色谱法建立注射用兰索拉唑有关物质检查及其含量测定方法。方法Diamonsil-C₁₈柱(4.6 mm×200 mm,5μm),以甲醇-水-三乙胺-磷酸(640∶360∶5∶1.5,pH为7.3)为流动相,检测波长为284 nm。结果制剂中辅料对主药测定无干扰,兰索拉唑与有关物质完全分离。在10.0～400.0 mg·L^-1内峰面积与浓度呈良好的线性关系。精密度(RSD=0.13%)良好。平均回收率为99.6%。结论本方法简便,迅速,准确,专属性强。

Determination of Lansoprazole and Its Related Substance in Lansoprazole for Injection by HPLC

OBJECTIVE To establish a HPLC method for determing the content of lansoprazole and screening its related substance in lansoprazole for injection.METHODS A Diamonsil-C₁₈ column(4.6 mm×200 mm,5 μm) was used.The mobile phase was methanol-water-triethylamine-phosphoric acid(640∶360∶5∶1.5,pH 7.3).The determination wavelength was 284 nm.RESULTS The excipients did not interfere with the determination of lansoprazole.Lansoprazole and its related substance were absolutely separated.The linear range of lansoprazole was 10.0～400.0 mg·L^-1.The precision of the method(RSD=0.13%)was good.The average recovery was 99.6%.CONCLUSION The method is simple,speedy,accurate and specific.