安乃近有关物质检查  

作　　者：黄红深[1] 

机构地区：[1]广东省广州市药品检验所,广州510160

出　　处：《北方药学》2011年第2期7-8,共2页Journal of North Pharmacy

摘　　要：目地:建立安乃近原料有关物质检查的方法。方法:采用高效液相色谱法,选择十八烷基硅烷键合硅胶为填充剂,磷酸盐缓冲液(磷酸二氢钠6.0g,加水1000ml,加三乙胺1ml,用氢氧化钠溶液调pH至7.0)-甲醇(75:25)为流动相;检测波长254nm。结果:安乃近及4-N去甲基安乃近在5～50μg/ml的范围内呈线性,线性方程分别为:安乃近Y=26255X+10511,r=0.9999(n=5);4-N-去甲基安乃近:Y=29955X+4199.3,r=0.9999(n=5);4-甲氨基安替比林在5～100μg/ml的范围内呈线性,线性方程为:4-甲氨基安替比林Y=21460X-4826,r=0.9999(n=6),样品溶液在光、热、酸、碱条件下均不稳定。结论:本方法稳定,操作简单,重现性好,可以有效控制安乃近中有关物质的量。Objective：To established an HPLC method to determine the related substances in Metamizole Sodium.Method：A column packed with octadecylsilane bonded silica gel was used and the mobile phase is the mixture of phosphate BS（Dissolve 6.0 g of monobasic sodium phosphate in 1000 ml of water,add 1 ml of triethylamine,adjust pH value to 7.0 with sodium hydroxide solution）-methanol（75：25） and the detection wavelength is 254 nm.Result：The linear range of metamizole sodium,4-N-nor metamizole sodium and 4-（methylamino）-antipyrin are 5～50μg/ml,5～50μg/ml and 5～100μg/ml respectively.The regression equation for metamizole sodium is Y=26255X＋10511,r=0.9999（n=5）;the regression equation for 4-N-nor metamizole sodium is Y=29955X＋4199.3,r=0.9999（n=5）;the regression equation for 4-（methylamino）-antipyrin is Y=21460X-4826,r=0.9999（n=6）.The test solution is unstable under the light,heat,acid and alkaline circumstance.Conlusion：The method is stable,simple and repeatable and can be used for quality control of the related substances in Metamizole Sodium.

关 键 词：安乃近 物质 检查 

分 类 号：R927.1[医药卫生—药学]