目的 建立HPLC测定阿维莫泮原料药中光学异构体的方法。方法 采用HPLC法，色谱柱为ULTRON ES-OVM柱（填料为卵类粘蛋白键和硅胶，150 mm×4.6 mm，5 μm）；以0.02 mol/L磷酸二氢钾缓冲液-乙腈（95：5）为流动相；体积流量：0.6 mL/min；检测波长：273 nm；柱温：30℃；进样量：20 μL。结果 在上述色谱条件下，阿维莫泮与光学异构体分离度符合要求，检测限为1 ng，精密度良好（RSD均小于2%）。结论 本方法操作简便，专属性强，灵敏度高，可用于阿维莫泮原料药中光学异构体的限量控制方法。

Objective To establish an HPLC method for determination of optical isomers in alvimopan active pharmaceutical ingredient. Methods HPLC method was adopted on ULTRON ES-OVM (150 mm×4.6 mm, 5 μm) column. The mobile phase consisted of acetonitrile-0.02 mol/L potassium dihydrogen phosphate buffer solution (5:95). The detection wavelengths were 273 nm. The flow rate was 0.6 mL/min, and the column temperature was set at 30℃ with injection volume of 20 μL. Results The resolution of alvimopan and optical isomers were good. The limit of detection was 1 ng, and the precision was good. Conclusion The method is convenient, highly specific, sensitive, and suitable to determine the limit of optical isomers in alvimopan active pharmaceutical ingredient.

天津市科技计划项目（15ZCZDSY00460）