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Application Brief

HPLC Analysis of Lamotrigine Related Compound B Impurity in Accordance with the USP Application Brief

Introduction

Lamotrigine is an antiepileptic drug belonging in the phenyl triazine class. It is used in the treatment of both epilepsy and as a mood stabilizer for bipolar disorder. Lamotrigine related compound B also known as 2,3-dichlorobenzoic acid is a key intermediate for the antiepileptic drug Lamotrigine. It may be in found in the final product and needs to be monitored and controlled over the shelf life of the product.

The methods for assessing Lamotrigine related compound B are described in the United States Pharmacopeia1 and rely on chromatographic techniques. This application brief describes use of an Epic C18 column coupled with the LC 300 liquid chromatography system and SimplicityChrom chromatography data system (CDS).