用高效液相色谱法测定双氯芬酸钠的杂质  

作　　者：黄红深[1] 

机构地区：[1]广州市药品检验所,广州510160

出　　处：《北方药学》2011年第1期3-4,共2页Journal of North Pharmacy

摘　　要：目的:建立双氯芬酸钠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,甲醇—0.12%冰醋酸溶液(60∶40)为流动相;检测波长240nm。结果:双氯芬酸钠在1～10μg/ml的范围内呈线性,线性方程为:Y=25803x+3632.4,r=0.9996(n=5),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,可以有效控制双氯芬酸钠中有关物质的量。Objective： To established an HPLC method to determine the related substances in diclofenae sodium. Method： A column packed with octadecylsilane bonded silica gel was used and the mobile phase is the mixture of methanol--0.12% acetic acid solution （60：40） and the detection wavelength is 240 nm. Result： The linear range of dielofenae sodium is 1-10μg/ml,. The regression equation for diclofenae sodium is Y=25803x-3632.4, r=0.9996 （n=5）. The test solution is unstable under the light, heat, aeid and alkaline circumstance. Conlusion： The method is stable, simple and repeatable and can be used for quality control of the related substances in dielofenae sodium.

关 键 词：高效液相色谱法双氯芬酸钠杂志 

分 类 号：R927.1[医药卫生—药学]