Abstract
A direct chiral high-performance liquid chromatography (HPLC) method was developed and validated for the resolution and quantification of antiepileptic drug enantiomers, R-(−)- and S-(+)-vigabatrin (gamma-vinyl-gamma-aminobutyric acid) in pharmaceutical products. The separation was optimized on a macrocyclic glycopeptide antibiotic chiral stationary phase (CSP) based on teicoplanin aglycone, chirobiotic (TAG), using a mobile phase system containing ethanol–water (80:20, v/v), at a flow rate of 0.4
ml/min and UV detection set at 210
nm. The stability of vigabatrin enantiomers under different degrees of temperature was also studied. The enantiomers of vigabatrin were separated from each other. The calibration curves were linear over a range of 100–1600
μg/ml (
r
=
0.999) for both enantiomers. The overall recoveries of R-(−)- and S-(+)-vigabatrin enantiomers from pharmaceutical products were in the range of 98.3–99.8% with %RSD ranged from 0.48 to 0.52%. The limit of quantification (LOQ) and limit of detection (LOD) for each enantiomer were 100 and 25
μg/ml, respectively. No interferences were found from commonly co-formulated excipients.