建立了高效液相色谱法检查阿昔莫司(1)原料药中的有关物质。采用 Ultimate XB-C18 色谱柱，流动相为甲醇-0.01 mol/L 四丁基氢氧化铵溶液(20 ∶ 80，用磷酸调至pH 6.0)，流速1.0 ml/min，检测波长220 nm。1 中的4 个杂质分别在0.1 ～ 1.5 或0.03 ～ 0.45 μg/ml 范围内线性关系良好；有关物质回收率为101.4％～ 102.9％，RSD 为0.9％～ 1.9％。本法定性可靠，定量准确，灵敏度高，为1 合成工艺的优化提供了支持，也提高了1 的质量控制水平。

An HPLC method was established for the determination of the related substances in acipimox(1). A Ultimate XB-C18 column was used, with the mobile phase of methanol-0.01 mol/L tetrabutylammonium hydroxide solution (20∶80, adjusted pH to 6.0 with phosphoric acid), at a flow rate of 1.0 ml/min and a detection wavelength of 220 nm. The calibration curves for 1 - 5 were linear in the ranges of 0.1 - 1.5 or 0.03 - 0.45 μg/ml. The recoveries for the impurity were 101.4％ - 102.9％, with RSDs of 0.9％ - 1.9％.The proposed method was simple, accurate and sensitive, and provided support for the optimization of the synthesis process, and also significantly improved the quality control level of 1.