高效液相色谱法测定头孢呋辛赖氨酸原料药的含量  

Determination of the content of cefuroxime lysine bulk drug by HPLC method

作　　者：王洁[1] 李清[1] 徐珊珊[1] 陈晓辉[1] 赵龙山[1] 毕开顺[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中国新药杂志》2013年第3期359-363,共5页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2009ZX09301-012)

摘　　要：目的:建立高效液相色谱法测定头孢呋辛赖氨酸原料药的含量。方法:采用Kromasil C8(250 mm×4.6 mm,5μm)色谱柱,流动相为pH 3.4,0.1 mol.L-1醋酸盐缓冲液-乙腈(85∶15),流速为1.0mL.min-1,柱温为35℃,检测波长为273 nm。结果:头孢呋辛在1.97～39.49μg.mL-1范围内,浓度与峰面积呈良好线性关系,相关系数r=0.999 8(n=7),平均回收率为99.6%(n=9,RSD=0.6%)。结论:本法操作简便,结果准确,可用于头孢呋辛赖氨酸原料药的含量测定。Objective：To establish a high performance liquid chromatography （HPLC） method for the de- termination of the content of cefuroxime lysine bulk drug. Methods：The Kromasil Cs column （250 mm × 4.6 mm, 5 μm） was used, and the mobile phase was composed of 0.1 mol· L^-1 acetate buffer （pH 3.4）-acetonitrile （85： 15） with a flow rate of 1.0 mL· min^-1 The detection was conducted at 273 nm, and the column temperature was maintained at 35 ℃. Results ： The linear range of the calibration curve for cefuroxime was 1.97 ~ 39.49 μg·mL^- 1 （R =0. 999 8 ,n =7）. The average recovery was 99.6% and RSD was 0.6% （n =9）. Conclusion：This method is simple, accurate and suitable for the determination of the content of cefuroxime lysine.

关 键 词：高效液相色谱 头孢呋辛赖氨酸 含量测定 

分 类 号：R917.795[医药卫生—药物分析学] R927.2[医药卫生—药学]