高效液相色谱法测定头孢噻吩钠含量和有关物质  

Content determination of cefalotin sodium and its related substances by high performance liquid chromatography

作　　者：唐倩[1] 杨元娟[1] 杨宪 曾正渝[1] 

机构地区：[1]重庆医药高等专科学校药学系,重庆400030 [2]重庆赛诺药业股份有限公司,重庆400041

出　　处：《激光杂志》2010年第3期91-92,共2页Laser Journal

基　　金：重庆市教育委员会立项资助项目(项目编号:KJ072201)

摘　　要：建立高效液相色谱法(HPLC)测定头孢噻吩钠含量和有关物质。色谱条件以C18为固定相,色谱柱:(4.6mm×250mm,5μm);流动相为0.207mol/L醋酸钠溶液(用冰醋酸调pH值至5.9)-乙醇-乙腈(82:2:16),流速为:1.0mL/min;检测波长:254nm:柱温;40℃。结果:头孢噻吩钠含量在55.8μg/mL至464.4μg/mL呈良好线性关系,r=0.9999:平均回收率100.2%;最低检测限为3ng(1ng/μL×3μL)。本法简单、准确,重现性、分离效果好,能较好的进行孢噻吩钠含量和有关物质测定。Objective：To study the high performance liquid chromatography（HPLC） method for the determination of cefalotin sodium and its related substances.Methods：The chromatographic conditions are as follow： column：C18（4.6mm×250mm,5μm）;mobile phase：0.207mol/L Sodium acetate aqueous solution（adjusted to pH 5.9 with acetic acid）-ethanol-acetonitrile（82： 2： 16）;flow rate： 1.0mL/min;detection wavelength：254nm;column temperature： 40℃.Results：The calibration cure of assay is linear when the concentration of cefalotin sodium in the range of 55.8～464.4μg/ml,r=0.9999,and the average recovery 100.2%.The limit of detection is 3ng（1ng/μl×3μl）.Conclusion：The method is simple and accurate with good reproducibility.It provides a new and reliable means for the quality control to content determination of cefalotin sodium and its related substances.

关 键 词：高效液相色谱法 头孢噻吩钠 含量 有关物质 

分 类 号：R927.2[医药卫生—药学]