硝酸咪康唑软膏有关物质检查方法的建立  

Establishment of Related Substance Examination in Metonazole Nitrate Ointment

作　　者：刘建华[1] 尹继业 杨德柱[1] 

机构地区：[1]齐齐哈尔医学院医药研究所,161042 [2]黑化集团大华经贸有限责任公司齐齐哈尔市消毒剂厂,161042

出　　处：《医药导报》2007年第9期1081-1083,共3页Herald of Medicine

摘　　要：目的建立硝酸咪康唑软膏有关物质检查方法。方法采用高效液相色谱法,色谱柱为十八烷基硅烷键合硅胶,0.5%醋酸铵溶液-乙腈和甲醇(1:1)混合液(200:900)为流动相,检测波长为230 nm。结果线性关系A=0.439 0C+0.411 9,r=0.999 9,重复性实验RSD=1.59%(n=5),检测限为0.33 ng。结论该方法简单、快速、准确,适用于软膏制剂的有关物质检查。Objective To establish the related substsnce examination in miconazole nitrate ointment by HPLC. Methods A C l8 column was used with the mobile phase of 0.5 % NH4 AC-CH3 CN and CH3 OH （ 1 ： 1 ） mixture solution （200 ： 900） . The detection wavelength was 230 nm . Results Linearity regression was A = 0.439 0 C ＋ 0.411 9 , r = 0. 999 9 . Repetitiveness RSD was 1.59% （ n = 5 ） . Detectability was 0.33 ng . Conclusion This method is single, rapid , and accurate , suitable for examining the related substance examination in ointment preparation.

关 键 词：硝酸咪康唑软膏 有关物质 色谱法 高压液相 

分 类 号：R978.5[医药卫生—药品] R927.1[医药卫生—药学]