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 0.4ml/min and UV detection set at 210nm. 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 100-1600microg/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 25microg/ml, respectively. No interferences were found from commonly co-formulated excipients.
TY - JOUR
T1 - A direct HPLC method for the resolution and quantitation of the R-(-)- and S-(+)-enantiomers of vigabatrin (gamma-vinyl-GABA) in pharmaceutical dosage forms using teicoplanin aglycone chiral stationary phase.
A1 - Al-Majed,Abdulrahman A,
Y1 - 2009/04/05/
PY - 2008/12/03/received
PY - 2009/03/23/revised
PY - 2009/03/25/accepted
PY - 2009/5/19/entrez
PY - 2009/5/19/pubmed
PY - 2009/8/6/medline
SP - 96
EP - 9
JF - Journal of pharmaceutical and biomedical analysis
JO - J Pharm Biomed Anal
VL - 50
IS - 1
N2 - 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 0.4ml/min and UV detection set at 210nm. 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 100-1600microg/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 25microg/ml, respectively. No interferences were found from commonly co-formulated excipients.
SN - 1873-264X
UR - https://www.unboundmedicine.com/medline/citation/19446423/A_direct_HPLC_method_for_the_resolution_and_quantitation_of_the_R______and_S__+__enantiomers_of_vigabatrin__gamma_vinyl_GABA__in_pharmaceutical_dosage_forms_using_teicoplanin_aglycone_chiral_stationary_phase_
L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(09)00205-2
DB - PRIME
DP - Unbound Medicine
ER -
