HPLC法测定维生素C注射液中EDTA-2Na的含量  

Determination of Disodium Edetate in Vitamin C for Injection by HPLC

作　　者：钱桂英[1] 钮晓淑[1] 袁华峰 

机构地区：[1]泰州市食品药品检验所,江苏泰州225300

出　　处：《中国药师》2013年第10期1461-1463,共3页China Pharmacist

基　　金：江苏省区域性食品药品检验检测公共技术服务中心平台项目(编号:BM2012024)

摘　　要：目的:建立维生素C注射液中乙二胺四乙酸二钠(EDTA-2Na)的含量测定方法。方法:色谱柱为Waters X bridge HILIC柱(250mm×4.6mm,5μm),流动相A为0.02mol·L^(-1)的乙酸铵(用冰醋酸调节pH至3.0),流动相B为乙腈,梯度洗脱,检测波长为270 nm,流速为1.0ml·min^(-1),进样量为20山。结果:EDTA-2Na浓度在15.73~78.66μg·ml^(-1)范围內,线性关系良好(r=0.9998),平均回收率为99.83%,RSD为1.2%(n=6)。结论:本法简便、准确、重复性好,可用于维生素C注射液申EDTA-2Na的含量测定。Objective ： To establish a method for the determination of disodium edetate in vitamin C for injection. Method ： A Wa- ters Xbridge HILIC column（250 mm ×4.6 mm,5 μm） was used with the mobile phase A of 0.02 mol · L-1 ammonium acetate （ad- justing pH to 3.5 with acetic acid） and mobile phase B of acetonitrile with gradient elution. The detection wavelength was set at 270 nm. The flow rate was 1.0 ml · min-1. Result： The standard curve was linear within the range of 15.73-78.66 μg · ml-l （r = 0. 999 8 ） , and the average recovery was 99.83 % with RSD of 1.2% （ n = 6）. Conclusion： The method is simple, accurate and repro- ducible, and suitable for the determination of disodium edetate in vitamin C for injection.

关 键 词：高效液相色谱法 维生素C注射液 乙二胺四乙酸二钠 含量测定 

分 类 号：R927.2[医药卫生—药学]