Isolation and characterization of process-related impurity in 5-ethyl-3-methyl-5-phenyl-imidazolidine-2, 4-dione(Mephenytoinanticonvulsant drug)

Krishnamoorthy Balamurugan, Ta

Abstract

One unknown impurity inMephenytoin bulkmaterial at a level 0.15%was detected by a reverse phase high performance liquid chromatography (HPLC). This impurity was isolated from a crude sample of Mephenytoin using reverse phase preparative LC. The impurity isolated by preparative LCwas characterized by IR, NMR, andMS experimental data. Based on the results obtained from different spectroscopic experiments, these impurity was characterized as 1, 3-Dimethyl-5, 5-phenylethyl hydantoin. Formation of this impurity is also discussed.