Abstract

DETERMINITAION OF BENZALDEHYDE GENOTOXIC IMPURITY IN LACOSAMIDE DRUG SUBSTANCES USING HPLC TECHNIQUE

Dr. Ritesh Kumar Srivastava*

ABSTRACT

Benzaldehyde has been highlighted as one of the potential genotoxic impurities (PGIs) in Lacosamide drug substances. A sensitive HPLC method was developed and validated for the determination of benzaldehyde in lacosamide drug substances. HPLC method on Kromasil C18 column (250 X 4.6 mm, 5μm), with UV detection at 250 nm was used. The proposed method was cost effective, specific, linear, accurate, rugged and precise. The calibration curves showed good linearity over the concentration range of 1.13 μg/g to 5.64 μg/g with respect to the sample and the correlation coefficient was 0.9981. Accuracy results were well in the range 96.28 to 101.41%. and method very sensitive.

Keywords: Impurity, HPLC, TTC, ICH guidelines, Validation.