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目的 建立HPLC测定赛利司他有关物质的方法.方法 采用Agilent Phenyl色谱柱(250 mm×4.6 mm,5 μm),以5 mmol.L-1磷酸二氢钾(用10％磷酸调pH值至4.0)-乙腈为流动相进行梯度洗脱,流速为1.0 mL·min-1,检测波长为226nm.结果 各杂质与主峰之间的分离度良好.开环杂质(杂质A)、2-十七烷基氧-6-甲基-4氢-3,1-苯并噁嗪-4-酮(杂质B)、2-十八烷基氧-6-甲基-4氢-3,1-苯并噁嗪-4-酮(杂质C)浓度分别在0.049 5～1.981 μg·mL-1,0.059 9～0.399 1 μg·mL-1,0.059 6～0.397 5 μg·mL-1内与峰面积呈良好的线性关系,r均为0.999 9;杂质A、B、C加样回收率的平均值分别为104.2％,107.0％和107.8％,RSD分别为2.09％,1.77％和2.18％.结论 本方法简便、准确可靠,适用于赛利司他中有关物质的控制.“,”OBJECTIVE To establish an HPLC method for determining the contents of the related substances of cetilistat.METHODS The condition of detection were as follows:Agilent Phenyl column (250 rnm×4.6 mm,5 tμm),the gradient mobile phase consisted of 5 mmol·L-1 potassium dihydrogen phosphate (adjust with 10％ phosphoric acid to pH 4.0) and acetonitrile with a flow rate of 1.0 mL·min-1,the UV detection wavelength was 226 nm.RESULTS The resolution of cetilistat and relate substances was good.The calibration curves were linear in the range of 0.049 5-1.981 0 μtg·mL-1 for impurity A (r=0.999 9);the calibration curves were linear in the range of 0.059 9-0.399 1 μtg·mL-1 for impurity B (r=0.999 9);the calibration curves were linear in the range of 0.059 6-0.397 5 μtg·mL-1 for impurity C (r=0.999 9).The average recoveries of impurity A,impurity B and impurity C were 104,2％,107.0％ and 107.8％ respectively;the RSDs were 2.09％,1.77％ and 2.18％,respectively.CONCLUSION The method is simple,accurate,reliable and can be used for the quality control of the related substances of cetilistat.