Abstract

BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF LACOSAMIDE IN RAT SERUM USING HPLC

Sadaf Siddiqui*, R. Vani, Danish Khan

ABSTRACT

A New, cost effective, simple, and rapid Bio-analytical HPLC method was developed and validated as per (ICH) guidelines for the determination of Lacosamide using Paracetamol as an Internal standard. Lacosamide is a new Anti-epileptic drug used to manage partial onset of seizures in humans with epilepsy. The mobile phase consisted of mixture of phosphate buffer and methanol at a flow rate of 0.8ml/min. Wavelength used was 246nm with a total run time of 20 minutes. The retention time of Paracetamol and Lacosamide was found to be 3.03 and 4.32 respectively .For the developed method System suitability criterion was met, Calibration curves were found to be linear giving regression of 0.999, method is Accurate as Recovery was 100%, Precise as RSD obtained was within limits, LOD and LOQ were calculated and found to be within limits, method is robust as all the parameters were within the acceptance criterion. The results showed that the method is cost effective, simple and suitable for application to a Bioequivalence, Pharmacokinetic and Drug interaction studies for the estimation of Lacosamide from Rat serum.

Keywords: Lacosamide, Anti-epileptic, ICH, Rat Serum, Cost effective, Bioequivalence, Drug interaction studies.