Mapping of Pharmaceutical Degradants of Gabitril Using Radiotracers

Gabitril is a new antiepileptic drug. HPLC/UV analysis indicates that stress-induced degradation of Gabitril tablets is very complex, leading to many degradation products. Strategies for alleviating the mass balance of the degradation using radiolabeled Gabitril are proposed. The extraction efficiency of [14C]Gabitril and its degradation products from the tablet formulation were determined after storage under various conditions. Degradation products greater than 0.1% were located by HPLC combined with fraction collection and radioactivity counting. The UV response factors of degradants relative to the Gabitril signal could be estimated by correlating UV and radioactivity profiles.