摘要
目的:建立同时测定艾司奥美拉唑钠原料药中潜在的有色杂质的测定方法。方法:对奥美拉唑与艾司奥美拉唑钠药典标准中的有色杂质检查项进行解读分析,采用紫外-可见分光光度法(UV-Vis),分别以甲醇和二氯甲烷为溶剂,在440nm和650nm的波长处针对已知杂质F和G进行对比研究。结果:检测溶剂为甲醇,检测波长为440nm和650nm,限度为吸光度均不得过0. 05。杂质F和G在0. 7μg/mL～10μg/mL的浓度范围内线性关系良好。结论:该方法简便、灵敏且准确,可用于艾司奥美拉唑钠中有色杂质的测定。
Objective：To establish a determination method for the potential colored impurity in esomeprazole sodium.Methods：Analyze the different pharmacopoeia standard of omeprazole and esomeprazole sodium,ultraviolet-visible spectrophotometry（UV-Vis） was conducted.make a contrastive study of impurity F and G at 440nm and 650nm using methanol and dichloromethane as solvents.Results：The light absorption of the substance being examined at 440nm and 650nm is not more than 0.05,take methanol as the solvent.Conclusions：The method is simple,sensitive and accurate,and can be used for the colored impurity in esomeprazole sodium.
作者
曹卫
郭梦玲
胡情姣
Cao Wei;Guo Mengling;Hu Qingjiao(Nanjing Heron Pharmaceutical Science Technology Co.,Ltd.,Nanjing 211100,China)
出处
《山东化工》
CAS
2018年第22期67-68,共2页
Shandong Chemical Industry
