离子色谱法测定注射用门冬氨酸钾镁中无水门冬氨酸钾镁含量

摘要

目的：建立测定注射用门冬氨酸钾镁中无水门冬氨酸钾镁含量的方法。方法：采用离子色谱法，色谱柱为CS12A（4 mm ×250 mm），保护柱为CG12A（4 mm ×50 mm）；电导检测器，阳离子抑制器；流动相为25 mmol· L-1甲烷磺酸溶液，流量为1 mL· min-1；柱温30℃。结果：无水门冬氨酸钾在22.08～441.64μg· mL-1范围内，色谱峰面积与其浓度成良好线性关系（Y＝0.0377X-0.0145，R2＝1），回收率为100.1％，RSD为0.7％；无水门冬氨酸镁在24.09～481.84μg· mL-1范围内，色谱峰面积与其浓度成良好线性关系（Y＝0.0409X-0.0088，R2＝1），回收率为100.9％，RSD为0.4％。结论：本方法可简便、快速、准确地对注射用门冬氨酸钾镁中无水门冬氨酸钾镁含量进行测定。%Objective:To establish an assay method of potassium aspartate and magnesium aspartate in potassium aspartate and magnesi -um aspartate for injection by ion chromatography (IC).Methods:The assay was performed on CS12A column(4 mm ×250 mm)and CG12A guard column (4 mm ×50 mm) with cationic suppressor and electrolytic conductivity detector.The mobile phase was 25 mmol · L-1 methanesulfonic acid solution with 1 mL· min-1 flow rate.The temperature of column was 30 ℃.Results: Within 22.08-441.64 μg· mL-1 potassium aspartate had a good linearity (Y=0.0377X-0.0145,R2 =1),the average recovery was 100.1% with RSD of 0.7%.Within 24.09-481.84 μg· mL-1 magnesium aspartate had a good linearity (Y=0.0409X-0.0088,R2 =1),the av-erage recovery was 100.9%with RSD of 0.4%.Conclusion:The method is proved to be simple ,rapid and sensitive for evaluating the quality of potassium aspartate and magnesium aspartate in potassium aspartate and magnesium aspartate for injection .