HILIC模式下UPLC-MS/MS测定多个注射剂中依地酸二钠含量  

Determination of Disodium Edetate in Multiple Injections by UPLC-MS/MS Based on HILIC

作　　者：刘晓强 刘毅[2] 蒋晓勤 LIU Xiao-qiang;LIU Yi;JIANG Xiao-qin(Changzhou Food and Drug Fiber Quality Supervision and Inspection Center,Changzhou 213102,China;National Institutes for Food and Drug Control,Beijing 102600,China)

机构地区：[1]常州市食品药品纤维质量监督检验中心,江苏常州213102 [2]中国食品药品检定研究院,北京102600

出　　处：《食品与药品》2023年第6期532-537,共6页Food and Drug

摘　　要：目的 建立并确证维生素C注射液、盐酸多巴胺注射液、注射用奥美拉唑钠、注射用泮托拉唑钠、注射用艾司奥美拉唑钠中依地酸二钠含量测定方法。方法 采用亲水作用色谱(HILIC)柱,以20 mmol/L乙酸铵溶液为流动相A,乙腈为流动相B进行梯度洗脱,流速为1.0 ml/min,采用电喷雾电离源,多反应监测模式进行检测。结果 专属性、线性及范围、重复性、中间精密度、加样回收率、检测限与定量限、耐用性均符合规定,对照品溶液及供试品溶液稳定性均较好。结论 该方法可用于测定维生素C注射液、盐酸多巴胺注射液、注射用奥美拉唑钠、注射用艾司奥美拉唑钠、注射用泮托拉唑钠中EDTA-2Na含量。Objective To establish and confirm a method for the determination of disodium edetate in Vitamin C Injection,Dopamine Hydrochloride Injection,Omeprazole Sodium for Injection,Pantoprazole Sodium for Injection and Esmeprazole Sodium for Injection.Methods HILIC column was adopted,and a gradient elution was performed at the flow rate of 1.0 ml/min,using 20 mmol/L ammonium acetate solution as mobile phase A and acetonitrile as mobile phase B.An electrospray ionization source and multi reaction monitoring mode was used for detection.Results The specificity,linearity and linear range,repeatability,intermediate precision,sample addition recovery,limit of detection and limit of quantification and durability could meet the detection requirements,and the stability of the control solution and the test solution were good.Conclusion The method can be used to determine the content of EDTA-2Na in Vitamin C Injection,Dopamine Hydrochloride Injection,Omeprazole Sodium for Injection,Esmeprazole Sodium for Injection and Pantoprazole Sodium for Injection.

关 键 词：依地酸二钠 亲水作用色谱(HILIC) UPLC-MS/MS 维生素C注射液 盐酸多巴胺注射液 注射用奥美拉唑钠 注射用艾司奥美拉唑钠 注射用泮托拉唑钠 

分 类 号：R917[医药卫生—药物分析学]