中国药师
中國藥師
중국약사
CHINA PHARMACIST
2015年
2期
319-323
,共5页
彭琳%刘雁鸣%龙海燕%廖彬
彭琳%劉雁鳴%龍海燕%廖彬
팽림%류안명%룡해연%료빈
注射用兰索拉唑%杂质%定量%定性
註射用蘭索拉唑%雜質%定量%定性
주사용란색랍서%잡질%정량%정성
Lansoprazole for injection%Impurities%Quantitative%Qualitative
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。
目的：：建立註射用蘭索拉唑有關物質測定方法,併對其雜質進行定性研究。方法：採用液相色譜及液相色譜-質譜聯用技術,DAD檢測器檢測,等度洗脫方式。結果：樣品中檢齣的單箇雜質為雜質B。結論：該方法簡便、快速、靈敏度高,可用于註射用蘭索拉唑有關物質的檢測。
목적：：건립주사용란색랍서유관물질측정방법,병대기잡질진행정성연구。방법：채용액상색보급액상색보-질보련용기술,DAD검측기검측,등도세탈방식。결과：양품중검출적단개잡질위잡질B。결론：해방법간편、쾌속、령민도고,가용우주사용란색랍서유관물질적검측。
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.
