Журнал хроматографии и методов разделения
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A Validated Chiral Liquid Chromatographic Method for the Enantiomeric Separation of Lacosamide Drug Product and its Dosage Forms

Charagondla K

A new and simple, rapid, selective isocratic normal phase liquid chromatographic (NP-LC) method was developed for the chiral purity of Lacosamide ((R)-2-acetamido-N-benzyl-3- methoxypropionamide) and its undesired S-enantiomer ((S)-2-acetamido-N-benzyl-3-methoxypropionamide). Superior resolution between Lacosamide and its S-enantiomer was achieved on Cellulose tris (3,5-Dichlorophenylcarbamate) immobilisation of polysaccharide derivatives based Chiralpak IC (25 mm × 4.6 mm, 5 μm) column using n-hexane : ethanol (85:15, v/v) as a mobile phase at 27°C column oven temperature. The USP resolution between the enantiomers was found more than five. Mobile phase flow was fixed at a rate of 1.0 mL/min and elution was monitored at 210 nm. The test concentration was 1000 μg/ml, Limit of detection and quantitative of S-enantiomer is 0.17 μg/mL and 0.48 μg/mL respectively. The percentage RSD of the peak area of six replicate injections of S-enantiomer at LOQ concentration was 5.8. The percentage recoveries of S-enantiomer from Lacosamide (LAC) were ranged from 105%-107%. The test solution and mobile phase were observed to be stable up to 48 h on bench top. The method was found to be selective, precise, linear, accurate and also robust. This method was successfully validated according to the International Conference Harmonization (ICH) guidelines.