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 scat-tering detection
张晓曦 1张磊1
作者信息
- 1. 徐州市检验检测中心药品监督检验所,江苏徐州 221000
- 折叠
摘要
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,3.5 μm),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 mL·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2～50 μg·mL-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.
Abstract
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 Wa-tersXbridgeC18Column(150 mm × 4.6 mm,3.5 μm)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 injec-tion.Results Kanamycin appeared linear relationship among 2-50 μg·mL-1,and the average recovery of the added stan-dard was 100.7％.Conclusion This method is repeatable and sensitive,providing a reference for the comprehensive estab-lishment of quality control methods for amikacin sulfate injection.
关键词
硫酸阿米卡星注射液/卡那霉素/蒸发光散射检测法Key words
Amikacin sulfate injection/Kanamycin/Evaporative light scattering detection引用本文复制引用
出版年
2024
NETL
NSTL
万方数据