Development of liquid chromatographic enantiomer separation methods and validation for the estimation of (R)-enantiomer in eslicarbazepine acetate.

摘要: Chiral separation method development was carried out for eslicarbazepine acetate and its (R)-enantiomer on diverse chiral stationary phases. Better selectivity observed cellulose tris-(3,5-dichlorophenylcarbamate) immobilized column (Chiralpak IC-3). Under polar organic mode (POM), with 100% acetonitrile as mobile phase 0.5 ml/min flow, a resolution close to three achieved. With normal (NP) consisting dichloromethane:ethanol (90:10, v/v) 1.0 six Detection done by UV at 220 240 nm respectively. Both the methods were found be robust validated respect robustness, precision, linearity, limit of detection, quantification accuracy. The proposed are suitable accurate estimation in bulk drug samples up 0.1% when 1 mg/ml analyte test solution is chromatographed.