摘要
目的:建立反向离子对色谱法测定氨甲苯酸片中氨甲苯酸含量的方法。方法:采用Agilent 5TC-C18150 mm×4.6μm色谱柱,用甲醇-0.005 mol·L^(-1)的十二烷基硫酸钠溶液(用磷酸调节pH至3.0)=55∶45为流动相,流速1.0 m L·min^(-1),柱温30℃,检测波长226 nm。结果:氨甲苯酸在约1.0~0.02 mg·m L^(-1)的浓度范围内线性关系良好(r=0.999 9);平均回收率为99.96%,RSD为0.15%(n=9),样品测定误差<0.1%。结论:本法经方法学验证,可用于氨甲苯酸片的质量控制。
Objective：To establish phase ion pair RP-HPLC methods for the determination of the concentration of aminomethylbenzoic acid tablets.Methods：The conventration of aminomethylbenzoic acid tablets were analyzed by phase ion pair RP-HPLC,theseparation was performed in a Agilent 5TC-C18 150mm×4.6μm column,with mobile methanol and 0.005mol？L-1 lauryl sulfatesolution （phosphoric acidregulate pH3.0）=55：45, the current speed was 1.0mL？min-1,column temperature was 30℃,the UV-detector at 226nm was selected.Result：The calibration curve was in good linearity over the range between about 1.0mg？mL-1and 0.02mg？mL-1 （r=0.9999）,the average recovery was 99.96%and RSD was 0.15%（n=9）,the measurable sample deviation〈0.1%.Conclusion：The method is verificated and can be used for quality control of aminomethylbenzoic acid tablets.
作者
李浩然
万彦
付小六
LI Haoran;WAN Yan;FU Xiaoliu(Luohe Center for Food and Drug Control, Luohe 462000, Chin)
出处
《中国药品标准》
CAS
2018年第1期54-57,共4页
Drug Standards of China
关键词
反向离子对色谱法
氨甲苯酸片
含量测定
reverse phase ion pair chromatography
aminomethylbenzoic acid tablets
assay
