高效液相色谱法测定氨甲苯酸对甲基苯甲酸和对羧基苯甲酸含量

Content analyzing of paratoluic acid and terephthalic acid in p-aminomethyl benzoic acid by HPLC

目的建立HPLC法同时测定氨甲苯酸中杂质对甲基苯甲酸和对羧基苯甲酸含量。方法采用高效液相色谱法[1],色谱柱C18柱,流动相,甲醇:乙腈:水:冰乙酸(25:15:60:1.5),检测波长为230nm。结果氨甲苯酸浓度在1.01～5.04μg/mL内与峰面积呈良好线性关系,最低检测限为0.86μg/mL。结论本法简便、准确,可用于控制氨甲苯酸原料药的质量。

Objective to establish an HPLC method for analyzing the content of paratoluic acid and terephthalic acid in p-aminomethyl benzoic acid at the same time.Methods HPLC1,column is octadecylsilane bonded silica gel（ODS）, mobile phase was made from methanol：acetonitrile：water：glacial acetic acid（25：15：60：1.5）,detecting wave length is 230nm.Results the peak area shows fine linear relationship when concentration of p-aminomethyl benzoic acid within 1.01～5.04μg/mL,limit of detection is 0.86μg/mL.Conclusion this method is simple and exact,can be used in quality controlling of the API,p-aminomethyl benzoic acid.