氨甲苯酸注射液及其有关物质的HPLC法测定

Determination of Aminomethylbenzoic Acid Injection and Its Related Substances by HPLC

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%.