应用离子对-蒸发光散射检测硫酸阿米卡星注射液中的卡那霉素效果初探

A preliminary study on quantitative detection of kanamycin in amikacin sulfate injection by ion-pair chromatography with evaporative light scattering detection

目的应用离子对-蒸发光散射检测法定量测定硫酸阿米卡星注射液中已知杂质卡那霉素。方法通过优化色谱条件,采用沃特世WatersXbridgeC18色谱柱(150 mm×4.6 mm,3.5μm),以0.2 mol·L^(-1)三氟乙酸溶液∶甲醇(90∶10)为流动相,流速为1.0 m L·min^(-1),漂移管温度为50℃,氮气压力为0.30 MPa。选择3个厂家的硫酸阿米卡星注射液进行分析。结果应用离子对-蒸发光散射检测法定量测定硫酸阿米卡星注射液中卡那霉素,卡那霉素在2~50μg·m L^(-1)浓度范围内呈线性关系,平均加标回收率为100.7%。结论本法重复性好,灵敏度高,为建立硫酸阿米卡星注射液的质量控制方法提供参考。

Objective To quantitatively detect known impurity kanamycin in amikacin sulfate injection by ion-pair chromatography with evaporative light scattering detection.Methods By optimizing chromatographic conditions,a WatersXbridgeC18Column(150 mm×4.6 mm,3.5μm)was used for the gradient elution.The mobile phase consisted of 0.2 mol·L^(-1)trichloroacetic acid-methanol(90∶10),the flow rate was 1.0 mL·min^(-1),the temperature of the drift tube was set to 50℃and the pressure of nitrogen was performed at 0.30 MPa.Three manufacturers were selected for analysis of amikacin sulfate injection.Results Kanamycin appeared linear relationship among 2-50μg·mL^(-1),and the average recovery of the added standard was 100.7%.Conclusion This method is repeatable and sensitive,providing a reference for the comprehensive establishment of quality control methods for amikacin sulfate injection.