Development of novel stability-indicating method for the determination of dimetindene maleate and its impurities
2013
Abstract
A novel and selective stability-indicating liquid chromatographic method has been developed and validated for the analysis of dimethindene maleate, the related substance 2-ethylpyridine, and three degradation products. Dimethindene maleate was subjected to forced degradation study by acid and basic hydrolysis, oxidation, and thermal decomposition.
Three degradation products that were formed during the forced degradation study were separated from dimethindene using a Zorbax SB CN column (150 x 4.6 mm; 5 micro m); cyanopropyl-bonded stationary phase was applied for the first time for the separation of dimethindene and its impurities.