RP-HPLC法测定诺氟沙星葡萄糖注射液中乙二胺四乙酸二钠的含量

Determination of Norfloxacin Glucose Injection in EDTA by RP-HPLC Method

目的建立诺氟沙星葡萄糖注射液中乙二胺四乙酸二钠的含量测定方法。方法选择色谱柱为(SHISEIDO C18-MGⅡ5μm 4.6×250 mm),流动相为乙腈:0.05 mol/L醋酸铵:水,流动相比例为70∶15∶15,流速为1.0 mL/min,进样体积为20μL,柱温为35℃,检测波长为254 nm,采用三氯化铁和乙二胺四乙酸二钠反应形成螯合物后对其进行测定。结果乙二胺四乙酸二钠峰与其他色谱峰分离度良好;乙二胺四乙酸二钠在2.0326~200.3260μg/mL浓度范围内与峰面积呈良好的线性关系(R^(2)=0.9997),平均回收率为98.11%(n=9)。结论该方法快速、简便、专属性强、精密度高、重复性好,结果准确可靠,适用于诺氟沙星葡萄糖注射液中乙二胺四乙酸二钠的含量测定。

Objective To establish a method for determination of norfloxacin glucose injection in compound EDTA injection. Methods The chromatographic column was Shiseido C18-MGⅡ5 μm 4.6×250 mm,with the mobile phase of acetonitrile: 0.05 mol/L ammonium acetate:water,mobile phase ratio of 70∶15∶15,flow rate of 1.0 mL/min,injection volume of 20 L,column temperature of 35 ℃,detection wavelength of 254 nm. The chelate from ferric chloride and EDTA disodium reaction were determined. Results EDTA-2 Na was detected without any interference. In the range and peak area of 2.032 6 μg/mL-200.326 0 μg/mL, EDTA-2 Na showed a good linear relation(R^(2)= 0.999 7),the average recovery was 98.11%(n = 9). Conclusion The method is rapid,simple,specific,reproducible,accurate and reliable,and is suitable for determination of EDTA in norfloxacin glucose injection.