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[摘要]
目的 建立HPLC法测定知非沙班中R异构体的方法。方法 采用HPLC法,以多糖衍生物共价键合手性柱Chirlpak®IA(250 mm×4.6 mm,5 μm)作为固定相;以甲醇–乙腈–二乙胺(90:10:0.1)作为流动相;检测波长:235 nm;柱温:35 ℃;体积流量为0.85 mL/min;进样体积:20 μL 。结果 知非沙班R异构体在0.007 5~1.000 0 μg/mL与峰面积线性关系良好(r=0.999 5),平均回收率为99.32%,RSD值为2.90%(n=12)。结论 本法操作简便快速,结果准确可靠,可用于知非沙班中R异构体的控制。
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[Abstract]
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.
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