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

作　　者：荣娜娜 李玉凤 任李玥 胡月新[3] RONG Na-na;LIYU-feng;REN Li-yue;HU Yue-xin(Yunnan Institute for Food and Drug Control,Kunming Yunnan 650106;Center for Food and Drug Inspection of Yunnan Province,Kunming Yunnan 650106;Science and Technology Achievement Incubation Center,Kunming Medical University,Kunming Yunnan 650500,China)

机构地区：[1]云南省食品药品监督检验研究院,云南昆明650106 [2]云南省食品药品审核查验中心,云南昆明650106 [3]昆明医科大学科技成果孵化中心,云南昆明650500

出　　处：《昆明医科大学学报》2021年第8期35-39,共5页Journal of Kunming Medical University

基　　金：云南省科技厅-昆明医科大学应用基础研究联合专项基金资助项目[2018FE001(-194)]。

摘　　要：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.

关 键 词：高效液相色谱法 诺氟沙星葡萄糖注射液 乙二胺四乙酸二钠 含量测定 

分 类 号：R917[医药卫生—药物分析学]