目的 建立HPLC測定阿維莫泮原料藥中光學(xué)異構(gòu)體的方法。方法 采用HPLC法，色譜柱為ULTRON ES-OVM柱（填料為卵類粘蛋白鍵和硅膠，150 mm×4.6 mm，5 μm）；以0.02 mol/L磷酸二氫鉀緩沖液-乙腈（95：5）為流動(dòng)相；體積流量：0.6 mL/min；檢測波長：273 nm；柱溫：30℃；進(jìn)樣量：20 μL。結(jié)果 在上述色譜條件下，阿維莫泮與光學(xué)異構(gòu)體分離度符合要求，檢測限為1 ng，精密度良好（RSD均小于2%）。結(jié)論 本方法操作簡便，專屬性強(qiáng)，靈敏度高，可用于阿維莫泮原料藥中光學(xué)異構(gòu)體的限量控制方法。

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.

天津市科技計(jì)劃項(xiàng)目（15ZCZDSY00460）