摘要
建立了高效液相色谱法测定氨甲苯酸注射液及其有关物质。采用C18色谱柱,以0.153 mol/L磷酸二氢钠溶液(含0.83%三乙胺及0.23%十二烷基硫酸钠,用磷酸调至pH 2.5)∶甲醇(60∶40)为流动相,检测波长230 nm。氨甲苯酸与各降解产物分离良好,在0.2~4和8~120ug/ml范围内线性关系良好,平均回收率为100.25%,RSD为0.51%。
An HPLC method was established for the determination of aminomethylbenzoic acid injection and its related substances. A C18 column was used with the mobile phase of 0.153 mol/L sodium dihydrogen phosphate solution (containing 0.83 % triethylamine and 0.23 % sodium lauryl sulfate, adjusted to pH 2.5 with phosphoric acid) : methanol (60 : 40), at the detection wavelength of 230 nm. Aminomethylbenzoic acid was successfully separated from its degradation products. It was linear in the ranges of 0.2 - 4 and 8 - 120 μg/ml. The average recovery was 100.25 %, with RSD of 0.51%.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2014年第10期956-958,961,共4页
Chinese Journal of Pharmaceuticals
关键词
氨甲苯酸注射液
有关物质
高效液相色谱
测定
aminomethylbenzoic acid injection
related substance
HPLC
determination