Synthesis and characterization of potential impurities of Vigabatrin-An anti epileptic drug

Abstract

The present work describes the synthesis and characterization of four potential impurities of Vigabatrin (1) namely 2-(2-aminobut-3-enyl)malonic acid (2) (Vigabatrin USP impurity-E), 2-(2-oxo-5-vinylpyrrolidin-1-yl)acetic acid (3) (USP Tablets impurity), 4-aminohexanoic acid (4) and 2,2′-oxo-5,5′-bispyrrolidinyl ether (5). Compound 4 is a possible process related impurity of 1 where as compound 5 is a process related impurity of 5-ethoxy-2-pyrrolinone (16). All these impurities have a significant impact on the quality of the drug product. This work is extremely useful for generic pharmaceutical industry.