Development of liquid chromatographic enantiomer separation methods and validation for the estimation of (R)-enantiomer in eslicarbazepine acetate.
J Pharm Biomed Anal
; 54(1): 248-51, 2011 Jan 05.
Article
in En
| MEDLINE
| ID: mdl-20832962
ABSTRACT
Chiral separation method development was carried out for eslicarbazepine acetate and its (R)-enantiomer on diverse chiral stationary phases. Better chiral selectivity was observed on cellulose tris-(3,5-dichlorophenylcarbamate) immobilized column (Chiralpak IC-3). Under polar organic mode (POM), with 100% acetonitrile as mobile phase and 0.5 ml/min flow, a resolution close to three was achieved. With normal phase (NP) mobile phase consisting dichloromethaneethanol (9010, v/v) and 1.0 ml/min flow, a resolution close to six was achieved. Detection was done by UV at 220 and 240 nm respectively. Both the methods were found to be robust and were validated with respect to robustness, precision, linearity, limit of detection, limit of quantification and accuracy. The proposed methods are suitable for the accurate estimation of (R)-enantiomer in bulk drug samples up to 0.1% when a 1mg/ml analyte test solution is chromatographed.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Chromatography, Liquid
/
Dibenzazepines
Language:
En
Journal:
J Pharm Biomed Anal
Year:
2011
Type:
Article
Affiliation country:
India