反相离子对色谱法分析注射用醋甘氨酸乙二胺含量和有关物质

Determination of Ethylenediamine Diaceturate Injection and of Related Substance by RP-MPIC

目的建立注射用醋甘氨酸乙二胺含量及有关物质的反相离子对色谱法分析方法。方法采用LichrosorbC18色谱柱(2500mm×46mm,5μm),以每100mL纯化水中加入庚烷磺酸钠014g,磷酸二氢钠052g,并用磷酸调节pH值至22为流动相,流速07mL·min1,检测波长200nm,室温操作。结果醋甘氨酸乙二胺在13~154μg·mL1范围内线性关系良好,r=09994,平均回收率9966%(RSD=119%)。醋甘氨酸乙二胺与其有关物质基线分离,最低检测限为048ng。结论该方法简便、快速、准确、灵敏,适用于注射用醋甘氨酸乙二胺的含量测定和有关物质的检查。

Objective To establish the determination of ethylenediamine diaceturate injection and of related substances by reverse phasemobile phase ion chromatography(RP-MPIC). Methods The Lichrosorb C_~18 column (250 mm×4.6 mm,5 μm) was used. The mobile phase were 100 mL water solution with 0.52 g sodium dihydrogen phosphate and 0.14 g sodium 1-heptanesulfonate dissolved (pH adjusted to 2.2 with phosphoric acid), and the flow rate was 0.7mL·min^-1 . The detective wavelength was 200 nm. Results A good linearity was obtained within 1.3-15.4 μg·mL^-1 (r=0.999 4). The average recovery of ethylenediamine diaceturate was 99.66% (RSD=1.19%). The limit of detection was 0.48 ng. Conclusion This method is simple, rapid and accurate. It can be used to assay ethylenediamine diaceturate and its related substance.