头孢拉定口服制剂有关物质的HPLC法分析  

The analysis of related substance for cefradine and its oral preparation by HPLC

作　　者：邱元素[1] 郭伟斌[1] 翁鹭娜[1] 李玲玲[1] 叶飞云[1] 

机构地区：[1]厦门市药品检验所,厦门361012

出　　处：《中国抗生素杂志》2004年第11期650-652,683,共4页Chinese Journal of Antibiotics

摘　　要：目的建立一种头孢拉定及其口服制剂有关物质的高效液相色谱分析法。方法色谱条件为C18柱,流动相A为磷酸二氢钠溶液,流动相B为磷酸二氢钠溶液-乙腈(55∶45),梯度洗脱,流速1.0ml/min,紫外检测波长为220nm。结果线性方程Y=19542.12X+45.28,最低检测限为1.0ng。结论筛选、优化出一种专属性强,灵敏度高,重现性好,能有效控制头孢拉定及其制剂质量的方法。Objective To establish the determination for related substance of cefradine and it′s oral preparation. Method Chromatographic conditions were as follows: C_~18 column , the mobile phase A sodium dihydrogen phosphate, the mobile phase B sodium dihydregen phosphate-acetonitrile (55∶45), flow rate 1.0 ml/min, gradient elution, the UV detection wave length 220nm. Result The linearity Y=19542.12X+45.28. The limit of detection (LOD) is 1.0ng. Conclusion The method was efficient, accurate, reproducible and feasible for determining related substance of cefradine and it′ oral preparation.

关 键 词：头孢拉定 有关物质 测定 高效液相色谱 

分 类 号：R927[医药卫生—药学]