Abstract
Isolation and characterization of process-related impurity inMephenytoin
Author(s): Krishnamoorthy Balamurugan, Kannan GokulakrishnanOne unknown impurity inMephenytoin bulk material 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 LC was characterized by IR, NMR, MS 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.
