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目的采用离子色谱法测定硫酸阿米卡星原料及其制剂的含量。方法采用戴安Carbopac MA1(250 mm×4 mm)色谱柱,80 mmol.L-1氢氧化钠溶液为淋洗液,流速0.4 mL.min-1,柱温30℃,工作电极为1 mm金电极。结果硫酸阿米卡星与各杂质分离良好,1.7～80.4μg·mL-1硫酸阿米卡星与峰面积的线性关系良好(r=0.9998),其最低定量限为9 ng,最低检测限为3 ng,平均回收率为99.1%。结论所用方法准确、简便、灵敏,能有效控制硫酸阿米卡星原料及其制剂的质量。
Objective To determine the content of amikacin sulfate raw materials and their preparations by ion chromatography. Methods A Carbopac MA1 (250 mm × 4 mm) column was used. The eluent was 80 mmol·L-1 sodium hydroxide solution and the flow rate was 0.4 mL.min-1. The column temperature was 30 ℃ and the working electrode was 1 mm gold electrode. Results The amikacin sulfate separated well from each impurity. The linear relationship between amikacin and the area of 1.7 ~ 80.4μg · mL-1 was good (r = 0.9998), the lowest limit of quantification was 9 ng, the lowest limit of detection was 3 ng, the average recovery was 99.1%. Conclusion The method is accurate, simple and sensitive, and can effectively control the quality of amikacin sulfate raw materials and their preparations.