摘要
目的:建立注射用兰索拉唑有关物质测定方法,并对其杂质进行定性研究。方法:采用液相色谱及液相色谱-质谱联用技术,DAD检测器检测,等度洗脱方式。结果:样品中检出的单个杂质为杂质B。结论:该方法简便、快速、灵敏度高,可用于注射用兰索拉唑有关物质的检测。
Objective： To establish the method for determining the related substances in lansoprazole for injection and qualitatively study the impurities. Methods： An HPLC method and an HPLC-MS method were used with isocratic elution and DAD as the detector.Results： The priciple impurity in all samples was impurity B. Conclusion： The method is fast,simple and sensitive,and suitable for the determination of the related substances in lansoprazole for injection.
出处
《中国药师》
CAS
2015年第2期319-323,共5页
China Pharmacist
关键词
注射用兰索拉唑
杂质
定量
定性
Lansoprazole for injection
Impurities
Quantitative
Qualitative
