高效液相色谱-蒸发光散射检测法测定硫酸阿米卡星  

HPLC -ELSD Determination of Amikacin Sulfate and Its Related Substances

作　　者：沈漪[1] 潘颖[1] 陈桂良[1] 

机构地区：[1]上海市药品检验所,上海200233

出　　处：《药物分析杂志》2004年第6期633-635,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立HPLC-ELSD法测定氨基糖苷类抗生素硫酸阿米卡星。方法:采用Zorbax Extend C18(150 mm×4.6mm,5μm)柱;以水-氨水-冰醋酸(96:3.6:0.4)为流动相,流速为0.4 mL·min-1;柱温:30℃;蒸发光散射检测,检测器漂移管温度:40℃,雾化气体压力:350 kPa。结果:硫酸阿米卡星在49.94-3995.5μg·mL-1范围内线性关系良好,r=0.9991;平均回收率为101.8%;系统精密度RSD=0.8%。同时阿米卡星与已知杂质A能良好分离。结论:本方法操作简便,快速,方法的精密度、准确性、重现性均能很好地满足质量控制的要求,是一种比较理想的阿米卡星含量测定分析方法。Objective: To establish an HPLC - evaporative light - scattering detection ( ELSD) method for the determination of amikacin sulfate and its related substances. Methods: The chromatography was performed on a column of Zorbax Extend C18 ( 150 mm ×4. 6 mm, 5μm) maintaining the temperature of 30℃ , using water - ammonia -glacial acetic acid (96: 3. 6:0. 4 ) as the mobile phase with the flow rate of 0. 4 mL·min-1. ELSD was used as the detector with pressure of nebulizing gas (air) of 350 kPa and the drift tube temperature of 40℃. Results: The calibration curve was linear in the range of 49. 94 - 3995. 5 μg·mL-1 ,r =0. 9991. The recovery was 101. 8% . Thesystem precision (RSD =0. 8% )was good. Basline separations of amikacin and its related substance A could be a-chieved under the above conditions. Conclusion: This method is simple,rapid,more precision,accurate and reproducible, provide an effective way in quality control of amikacin and its related substances.

关 键 词：高效液相色谱 蒸发光散射检测法 测定 硫酸阿米卡星 抗生素 

分 类 号：R927.2[医药卫生—药学] R978.1