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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

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【作者】 肖敏申景丰蒋芙蓉杨一刘再徳赵俭

【Author】 Xiao Min;Shen Jingfeng;Jiang Furong;Yang Yi;Liu Zaide;Zhao Jian;Hunan Provincial Center for Drug Evaluation and Adverse Reaction Monitoring;Hunan Kelun Pharmaceutical Co.,Ltd.;Sichuan Kelun Pharmaceutical Co.,Ltd.;

【通讯作者】 赵俭;

【机构】 湖南省药品审评与不良反应监测中心湖南科伦制药有限公司四川科伦药业股份有限公司

【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。

【Abstract】 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 m L/min. Column temperature: 30 ℃. Injection volume: 25 μL.Result: Sodium ions showed a good linear relationship in the range of 20~60 μg/m L, 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.

  • 【文献出处】 山西化工 ,Shanxi Chemical Industry , 编辑部邮箱 ,2024年07期
  • 【分类号】TQ460.72;O657.7
  • 【下载频次】21
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