Abstract

DEVELOPMENT OF A HIGHLY SENSITIVE METHOD FOR QUANTITATIVE ESTIMATION OF POTENTIAL GENOTOXIC OBOC IMPURITY IN LACOSAMIDE DRUG SUBSTANCES USING LCMS

Dr. Amit Gosar, Amit Joglekar, Gulab Gorde*, Deepak Kadam and Lahu Shelar

Abstract

A selective and highly sensitive liquid chromatography-mass spectrometry (LC-MS) method is developed for the determination of Sodium (tert-butoxycarbonyl)-D-serinate (O-Boc impurity) in Lacosamide drug substance. The method was partially validated as per International Council for Harmonisation (ICH) guidelines, for which limit of detection and limit of quantitation obtained were 0.302 ppm and 0.917 ppm respectively. The regression coefficient found for the linearity study was 0.9976. The % recovery of the spiked Sodium (tertbutoxycarbonyl)- D-serinate (O-Boc impurity) in drug substance obtained was in the range of 80 to 120 which ensure the accuracy of the method. The method can be adapted to determine Sodium (tertbutoxycarbonyl)- D-serinate (O-Boc impurity ) in Lacosamide drug substance (API).

Keywords: Lacosamide, Sodium (tert-butoxycarbonyl)-D-serinate (O-Boc), development, validation, LCMS.