建立了超高效液相色谱法测定甲磺酸达比加群酯原料药中的有关物质。采用C_(18)色谱柱,以10 mmol/L乙酸铵溶液(用冰乙酸调至pH 5.0)∶乙腈为流动相,梯度洗脱,检测波长280和310 nm。甲磺酸达比加群酯及6个已知有关物质均在0.40~30μg/ml范围内线性关系良好。有关物质回收率为94.7%~102.5%,RSD为0.56%~2.74%。 A high performance liquid chromatography was developed for the determination of related substances in dabigatran etexilate methanesulfonate. The C_ (18) column was used with a gradient of 10 mmol / L ammonium acetate (adjusted to pH 5.0 with glacial acetic acid): acetonitrile as mobile phase. The detection wavelength was at 280 and 310 nm. There was a good linear relationship between dabigatran etexilate and six known related substances in the range of 0.40 ~ 30μg / ml. Recoveries of related substances ranged from 94.7% to 102.5% with RSDs ranging from 0.56% to 2.74%.