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

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.