目的 建立HPLC法測定知非沙班中R異構(gòu)體的方法。方法 采用HPLC法，以多糖衍生物共價鍵合手性柱Chirlpak®IA（250 mm×4.6 mm，5 μm）作為固定相；以甲醇–乙腈–二乙胺（90：10：0.1）作為流動相；檢測波長：235 nm；柱溫：35 ℃；體積流量為0.85 mL/min；進樣體積：20 μL 。結(jié)果 知非沙班R異構(gòu)體在0.007 5～1.000 0 μg/mL與峰面積線性關(guān)系良好（r=0.999 5），平均回收率為99.32%，RSD值為2.90%（n=12）。結(jié)論 本法操作簡便快速，結(jié)果準(zhǔn)確可靠，可用于知非沙班中R異構(gòu)體的控制。

Objective To establish an HPLC method for the determination of R optical isomer in zifaxaban. Methods The HPLC was performed on a Chirlpak® IA column (250 mm × 4.6 mm, 5 μm). Methanol-acetonitrile-diethylamine (90:10:0.1) was used as mobile phase. The detective wavelength was set at 235 nm. The temperature of column was set at 35 ℃. The flow rate was 0.8 mL/min with injection volume of 20 μL.Results A good linear relationship was obtained in the range of 0.007 5 —1.000 0 μg/mL (r= 0.999 5), and the average recovery was 99.32% with RSD of 2.90% (n=12). Conclusion The method is convenient, rapid, accurate, and can be used for the determination of zifaxaban R optical isomers.