离子色谱法测定硫酸阿米卡星原料及其制剂的有关物质

Ion chromatography determination of related substances in amikacin sulfate raw materials and its preparations

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 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 ram）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-], 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.