离子色谱法测定硫酸阿米卡星原料及其制剂的有关物质

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0.9~4.8 μg·mL^-1(r=0.9994)内线性关系良好,阿米卡星杂质A在1.0~8.1 μg·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 estabilish a ion chromatography method for determination of the related substances in amikacin sulfate raw materials and its preparations. Methods: An Carbopac MA1(250 mm×4 mm)column was used with the eluent of deionized water (A) and 400 mmol·L^-1 sodium hydroxide solution (B),the flow rate was 0.4 mL·min^-1,the column temperature was 35 ℃.Amperometric detector,working electrode was gold electrode (1 mm). Results: The linear rang of amikacin was 0.9-4.8 μg·mL^-1 (r=0.9994),and the linear rang of amikacin impurity A was 1.0-8.1 μg·mL^-1(r=0.9994).The precisions (RSD) of amikacin and amikacin impurity A were 1.8% and 1.9%,the detection limits were 3.6 ng and 3.2 ng respectively.The sample solution was stable within 10 h. Conclusion: This method was simple,sensitive and can be applied for the related substances of amikacin raw materials and its preparations.

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