RP-HPLC法测定咪达唑仑糖浆有关物质  

Determination of Related Substances of Midazolam Syrup by RP-HPLC

作　　者：程霞[1] 陈亮[1] 黄丽娜[1] 王国海[1] 李春明[1] 

机构地区：[1]江苏恩华药业股份有限公司,江苏徐州221007

出　　处：《福建分析测试》2010年第2期76-79,共4页Fujian Analysis & Testing

摘　　要：目的:本文建立了反相高效液相色谱方法测定咪达唑仑糖浆有关物质。方法:采用大连依利特C18 ODS(5μm,4.6mm×250mm)色谱柱,以甲醇-0.0672%醋酸铵溶液(60:40)为流动相,检测波长为220nm,流速1.0ml/min。结果:在此条件下,咪达唑仑与有关物质得到有效分离,咪达唑仑糖浆的最低检测限为0.08ng。结论:本方法灵敏度高,专属性好,简便快速,可用于咪达唑仑糖浆有关物质的测定。Objective：To establish RP-HPLC method for the determnation related substances of midazolam syrup. Method： The separation was performed on Hypersil ODS C18 column （250mm ×4.6mm, 5 μ m）. The mobile phase consisted of methanol-0. 0672% ammonium acetate （60： 40） with a flow rate of 1.0ml/min. The detection wavelength was at 254nm. Results： A satisfactory separation condition among midazolam and the related impurities was obtained. The detection limit of midazolam syrup was 0.08ng. Conclusions： The method was sensitive, specificity and rapid, which can be used for determination of related substances of midazolam syrap.

关 键 词：咪达唑仑 糖浆 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]