Williams R C, Miyawa J H, Boucher R J, Brockson R W
DuPont Pharmaceuticals Company, Wilmington, DE 19880-0353, USA.
J Chromatogr A. 1999 Jun 4;844(1-2):171-9. doi: 10.1016/s0021-9673(99)00172-7.
A chiral HPLC separation on an alpha 1-acid glycoprotein (AGP) column was developed for the separation of roxifiban, a fibrinogen receptor antagonist, from its related chiral impurities. The proposed method was optimized for mobile phase buffer concentration, organic modifier, and temperature using experimental design. The method was then validated for use in release testing of the roxifiban drug substance.
开发了一种在α1-酸性糖蛋白（AGP）柱上进行手性高效液相色谱分离的方法，用于从其相关手性杂质中分离出纤维蛋白原受体拮抗剂罗昔非班。使用实验设计对流动相缓冲液浓度、有机改性剂和温度进行了优化。然后对该方法进行验证，以用于罗昔非班原料药的释放测试。
