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目的:建立测定硫酸阿米卡星原料及其制剂有关物质的离子色谱方法。方法:采用Carbopac MA1(250 mm×4 mm)色谱柱,以去离子水为淋洗液A,400 mmol·L-1氢氧化钠溶液为淋洗液B,梯度洗脱,流速:0.4 mL·min-1,柱温为35℃,安培检测器,工作电极为金电极(1 mm)。结果:阿米卡星在0.9～4.8μg·mL-1(r=0.9994)内线性关系良好,阿米卡星杂质A在1.0～8.1μg·mL-1(r=0.9994)内线性关系良好;阿米卡星与阿米卡星杂质A精密度(RSD)分别为1.8%及1.9%;检测限分别为3.6 ng及3.2 ng;供试品溶液在10 h内稳定性良好。结论:该方法简便、准确、灵敏,可用于硫酸阿米卡星原料及其制剂的有关物质测定。
Objective: To establish a method for the determination of amikacin sulfate raw materials and their related substances by ion chromatography. METHODS: Carbopac MA1 (250 mm × 4 mm) column was used. The eluate was eluted with deionized water A and 400 mmol·L-1 sodium hydroxide solution was used as eluent B. The flow rate was 0.4 mL · min-1, column temperature 35 ℃, amperometric detector, the working electrode is a gold electrode (1 mm). Results: The linearity of amikacin was good in the range of 0.9-4.8 μg · mL-1 (r = 0.9994), the linearity of amikacin A was good in 1.0-8.1 μg · mL-1 (r = 0.9994) The precision of amikacin and amikacin impurity A was 1.8% and 1.9%, respectively. The detection limits were 3.6 ng and 3.2 ng respectively. The stability of the test solution was good within 10 h. Conclusion: The method is simple, accurate and sensitive and can be used for the determination of related substances of amikacin sulfate raw materials and their preparations.