离子色谱法测定左氧氟沙星氯化钠注射液中的氯化钠含量方法研究  

Study on the Method of Determining Sodium Chloride Content in Levofloxacin and Sodium Chloride Injection by Ion Chromatography

作　　者：肖敏 申景丰 蒋芙蓉 杨一 刘再徳 赵俭 Xiao Min;Shen Jingfeng;Jiang Furong;Yang Yi;Liu Zaide;Zhao Jian(Hunan Provincial Center for Drug Evaluation and Adverse Reaction Monitoring,Changsha Hunan 410013,China;Hunan Kelun Pharmaceutical Co.,Ltd.,Yueyang Hunan 414100,China;Sichuan Kelun Pharmaceutical Co.,Ltd.,Chengdu Sichuan 610000,China)

机构地区：[1]湖南省药品审评与不良反应监测中心,湖南长沙410013 [2]湖南科伦制药有限公司,湖南岳阳414100 [3]四川科伦药业股份有限公司,四川成都610000

出　　处：《山西化工》2024年第7期76-78,共3页Shanxi Chemical Industry

摘　　要：目的:建立离子色谱法测定左氧氟沙星氯化钠注射液中的氯化钠含量方法。方法:用阳离子交换柱Dionex IonPacTMCS12A(250 mm×4 mm);保护柱:DionexIonPacTM CG12A(50 mm×4 mm);以20 mmol/L甲烷磺酸溶液为流动相,等度洗脱;采用阳离子抑制器和电导检测器检测;流速:1.0 mL/min;柱温:30℃;进样体积:25μL。结果:钠离子在20~60μg/mL范围内呈良好的线性关系,相关系数r=1.0;重复性实验RSD为0.31%;中间精密度RSD为0.36%;平均加样回收率为98.5%;样品在48 h内稳定;柱温和流速在一定范围内改变,对检测结果无影响。结论:该方法可准确测定左氧氟沙星氯化钠注射液中氯化钠含量。Objective:To establish an ion chromatography method for determining the content of sodium chloride in levofloxacin sodium chloride injection.Method:Dionex IonPacTMCS12A(250 mm×4 mm)cation exchange column was used.Protective column:Dionex InPacTM CG12A(50 mm x 4 mm).Using a 20 mmol/L methane sulfonic acid solution as the mobile phase,perform isocratic elution.Using cation suppressors and conductivity detectors for detection.Flow rate:1.0 mL/min.Column temperature:30℃.Injection volume:25μL.Result:Sodium ions showed a good linear relationship in the range of 20~60μg/mL,with a correlation coefficient of r=1.0.The RSD of the repeatability experiment is 0.31%.Intermediate precision RSD=0.36%.The average sample recovery rate is 98.5%.The sample remains stable within 48 hours.Changing the column temperature and flow rate within a certain range has no effect on the detection results.Conclusion:This method can accurately determine the content of sodium chloride in levofloxacin sodium chloride injection.

关 键 词：离子色谱法 左氧氟沙星氯化钠注射液 氯化钠 

分 类 号：O657.75[理学—分析化学]