离子色谱法测定氨甲环酸注射液中依地酸二钠的含量

目的:建立氨甲环酸注射液中依地酸二钠的含量测定方法。方法:采用离子色谱法测定。使用Ionpac AS14A阴离子分离柱,Ionpac AG14A保护柱,淋洗液为含5 mmol·L^-1碳酸钠、1 mmol·L^-1碳酸氢钠的混合溶液,流速为1.0 mL·min^-1,ASRS-ULTRA 4 mm自动抑制循环模式,抑制电流为50 mA,电导检测池温度为35℃,进样量为25 μL。由依地酸二钠标准工作曲线直接测得氨甲环酸注射液中依地酸二钠含量。结果:依地酸二钠浓度在5.226~209.0 μg·mL^-1范围内呈良好的线性关系(r ＝0.9981);平均回收率(n=3)为97.4%~100.1%。结论:本方法简单、快速,可以用于氨甲环酸注射液中依地酸二钠含量的测定。

Objective:To establish an ion chromatography(IC) method for the determination of disodium edetate in tranexamic acid injection. Methods:The determination was performed on an Ionpac AS14A column(4 mm×250 mm) with an Ionpac AG14A guard column(4 mm×50 mm) using a mixture of sodium carbonate 5 mmol·L^-1 and sodium bicarbonate 1 mmol·L^-1 as the mobile phase at a flow rate of 1.0 mL·min^-1.A conductivity detector and an ASRS suppressor were used as ASRS-ULTRA(4 mm) was set at an automatic restrain circulation pattern,with inhibit current of 50 mA,conductivity detection pool at 35℃,sample quantity of 25 μL.The content of disodium edetate in tranexamic acid injection was detected directly by the standard working curve of disodium edetate. Results:The standard curve was linear over the range of 5.226-209.0 μg·mL^-1(r ＝0.9981).The average recovery(n=3) was 97.4%-100.1%. Conclusions:The method is simple,accurate,and suitable for the determination of disodium edetate in tranexamic acid injection.

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