Optimization and validation of chiral high-performance liquid chromatographic method for analysis of a fibrinogen (gpIIb/IIIa) receptor antagonist.

Abstract

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