Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ASSAY OF LACOSAMIDE INJECTION

N. Jayasimha*, V.Krishna Reddy, V.Sandeep and E. Sasi Kiran Goud

ABSTRACT

A simple, sensitive and accurate gradient reverse phase high performance liquid chromatography method was developed for determination of lacosamide in injections. The effective separation was achieved on inert, sustain HP C18, 100 x 4.6 mm, 3 μm. The mixture of buffer and acetonitrile in the ratio 90: 10v/v used as a mobile phase-A. The buffer was prepared as 1.36 g of potassium dihydrogen phosphate in 1000 ml of purified water and adjusts the pH 2.0 with diluted orthophosphoric acid. The mixture of acetonitrile and water in the ratio of 60: 40 (v/v) used as mobile phase-B. The flow rate of the mobile phase was 1.5 mL/min and the total elution time was 10 minutes. The UV detection wavelength was carried at 210 nm and experiments were conducted at 45°C. The developed method was validated in terms of system suitability, selectivity, linearity, precision, accuracy, limits of detection and quantification for the impurities following the ICH guidelines.

Keywords: Lacosamide, Method development, Validation and RP-HPLC