诺氟沙星有关物质检查法的改进  

Improvement of Related Substances Method for Norfloxacin

作　　者：易大为[1] 刘梦琳[2] 张亚杰[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023 [2]山东省出入境检验检疫局岚山办事处,日照276808

出　　处：《中国药品标准》2013年第3期203-207,共5页Drug Standards of China

摘　　要：目的:改进诺氟沙星有关物质的高效液相测定方法。方法:采用C18色谱柱;流动相A为醋酸铵高氯酸钠溶液-乙腈(86∶14),流动相B为乙腈,梯度洗脱;检测波长262 nm和278 nm;流量1.0 mL·min-1。结果:改进后的测定方法提高了杂质检测的灵敏度,基线更稳定,各杂质峰均能与主峰较好地分离;其中杂质A在0.07～1.4μg·mL-1呈线性(r=0.999 8),加样平均回收率为99.5%,RSD为0.4%(n=9)。结论:本方法稳定、准确、可靠。Objective：To improve related substances method for norfloxacin. Method：The HPLC system was performed on a C18 column by linear gradient elution consisting of mobile phase A： ammonium acetate and sodium perchlorate solution-acetonitrile（86： 14） , and mobile phase B： acetonitrile. The flow rate was 1.0 mL·min^-1 and UV detector at 262 nm and 278 nm. Result： Impurity detection sensitivity was increased, and the baseline was stabler, and impurities peak could separate better with the prominent peak by the im-proved determination method. There was a good linearity in the range of 0. 07-1.4μg·mL^-1 of Norfloxacin impurity A, and the aver-age recovery was 99. 5% with RSD =0. 4% （n =9）. Conclusion： The method was stable,accurate and suitable.

关 键 词：诺氟沙星 有关物质 高效液相色谱 梯度 

分 类 号：R921.2[医药卫生—药学]