High-performance liquid chromatographic method for direct resolution of the indobufen enantiomeric components.
A high-performance liquid chromatographic method for the determination of (S)-(+)- and (R)-(-)-indobufen as diastereoisomeric derivatives has been applied and validated for stability control in tablet formulations. In order to obtain a less troublesome and more rapid method the direct resolution of the enantiomeric components by chiral stationary phases was investigated. The direct separation of the enantiomers was achieved using the cellulose tris(3,5-dimethylphenylcarbamate) derivative Chiralcel OD as a chiral stationary phase. The method was validated for the determination of the optical purity of (S)-(+)-indobufen as a quality control method for finished dosage forms.
Perrone
G
G
Galenical Research and Development, Farmitalia Carlo Erba, Milan, Italy.
Farina
M
M
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003505:Cyclodextrins; D004304:Dosage Forms; D006863:Hydrogen-Ion Concentration; D054833:Isoindoles; D010654:Phenylbutyrates / Q000032:analysis*; D010975:Platelet Aggregation Inhibitors / Q000032:analysis*
D003505:Cyclodextrins; D004304:Dosage Forms; D054833:Isoindoles; D010654:Phenylbutyrates; D010975:Platelet Aggregation Inhibitors; C020371:indobufen