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目的:建立测定门冬氨酸钾镁注射液中钾、镁和钠离子含量的方法。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);检测器采用带DIONEX AERS?500 4-mm抑制器的电导检测器;流动相为20mmol·L~(-1)甲烷磺酸溶液,流量为1 mL·min-1;柱温30℃。结果:钾在4.56~18.24μg·mL~(-1)范围内,色谱峰面积与其质量浓度呈良好线性关系(Y=0.393 6 X+0.066 1,r=0.999 9),回收率为100.2%,RSD为0.82%;镁在1.68~6.72μg·mL~(-1)范围内,色谱峰面积与其质量浓度呈良好线性关系(Y=1.000 3 X-0.163 6,r=0.999 8),回收率为100.1%,RSD为0.65%;钠离子在0.14~1.4μg·mL~(-1)范围内,色谱峰面积与其质量浓度呈良好线性关系(Y=0.600 4 X+0.004 1,r=1.0000),回收率为99.79%,RSD为0.61%。结论:本方法可简便、快速、准确地对门冬氨酸钾镁注射液中钾、镁和钠离子含量进行测定。
Objective: To establish a method for determination of potassium, magnesium and sodium in potassium and magnesium aspartate injection. METHODS: Ion chromatography was used with a CS12A column (4 mm × 250 mm) and a guard column of CG12A (4 mm × 50 mm). The detector was equipped with a conductivity detector with a DIONEX AERS ™ 500 4-mm suppressor. The flow The phase was 20 mmol·L -1 methanesulfonic acid solution and the flow rate was 1 mL · min-1. The column temperature was 30 ℃. Results: The range of potassium was in the range of 4.56-18.24μg · mL -1. The peak area was linear with the mass concentration (Y = 0.393 6 X + 0.066 1, r = 0.999 9). The recovery was 100.2% RSD was 0.82%, and the range of 1.68 ~ 6.72μg · mL ~ (-1) was linear with the concentration of magnesium (Y = 1.000 3 X-0.163 6, r = 0.999 8) 100.1% and RSD 0.65%. The linear range of the chromatographic peak area was 0.14-1.4 μg · mL -1 for sodium ion (Y = 0.600 4 X + 0.004 1, r = 1.0000) The recovery was 99.79% with a RSD of 0.61%. Conclusion: The method can be simple, rapid and accurate determination of potassium, magnesium and sodium in potassium and magnesium aspartate injection.