高效液相色谱法测定呋苄西林钠含量与有关物质  

Determination of furbenicillin sodium and its related substances by HPLC

作　　者：潘颖[1] 项竞佐[1] 刘浩[1] 仇仕林[1] 

机构地区：[1]上海市药品检验所抗生素室,上海200233

出　　处：《中国抗生素杂志》2006年第12期753-754,767,共3页Chinese Journal of Antibiotics

摘　　要：目的建立呋苄西林钠含量与有关物质的HPLC分析方法。方法采用ODS柱，以磷酸盐缓冲液（0．05mol／L磷酸二氢钾溶液，用磷酸调节pH值至3．5）：乙腈（75：25）为流动相A；以磷酸盐缓冲液：乙腈（20：80）为流动相B，含量测定以流动相A进行等度洗脱，有关物质测定采用线性梯度洗脱，流速为1．0ml／min，检测波长为254nm。结果呋苄西林在0．0964～19．29μg的范围内，进样量与峰面积的线性关系良好（r=0．9999），最低检测限为1．2ng。结论本方法可用于呋苄西林钠的有关物质及含量测定，方法专属性强，重现性好，操作简便。Objective To establish a new method for determination of furbenicillin sodium and its related substances. Method An ODS column was used. Mobile phase A. phosphate buffer （0.05mol/L potassium dihydrogen phosphate solution, pH adjusted to 3.5 by phosphoric acid） t acetontrile （75 ： 25）, mobile phase B. phosphate buffer ： acetontrile （20 ： 80）, isocratical elution was used for content determination and linear gradient elution for related substances. The flow rate was 1.0ml/min. The detection wavelength was 254nm. Results The relationship between sample sizes （a range from 0. 0964μg to 19.29μg） and peak areas had showed a good linearity （correlation coefficient r=0. 9999）. The detection limit is 1.2ng. Conclusion The method can be used to analyze furbenicillin sodium qualatively and quantitively. The method is easy, highly specific, efficient and reproducible.

关 键 词：呋苄西林钠 有关物质 含量测定 高效液相色谱 

分 类 号：R978.11[医药卫生—药品]