摘要
建立高效液相色谱法测定兰索拉唑中已知杂质的方法。方法:采用Agilent C18(4.6 mm×250 mm,5μm)色谱柱,流动相A为水,B为V(乙腈)∶V(水)∶V(三乙胺)=160∶40∶1的混合液,用磷酸调节pH至7.0,梯度洗脱,检测波长284nm,流速1mL/min,进样量20μL。结果:兰索拉唑与各已知杂质均分离良好,最低检测限与最低定量限分别为1.0~2.0ng与3.0~4.0ng。结论:该方法简便、快速、灵敏度高,可用于兰索拉唑杂质的检查。
The study established an HPLC method for the determination of known impurities in Lansoprazole. It adopted a Agilent C18 （250mm × 4.6ram, 5pro） column, pure water （A）-aeetonitrile： water： triethylamine （160.40 ： 1） （B） , adjusted to pH = 7.0 by phosphoric acid as mobile phases, with the detection wavelength of 284 nm,the flow rate of 1.0mL - min 1 and the injection volume of 20μL. Experiments show that Lansoprazole and its impurities were well separated ,and the limit of detection （LOD） and limit ofquantification （LOQ） of lansoprazole impurities were between 1-2ng and3-4ng, respectively. The results show that the method is fast, simple and sensitive, and suitable for the determination of the impurities in lansoprazole.
出处
《湖北工业大学学报》
2017年第1期109-111,共3页
Journal of Hubei University of Technology
