Development and validation of a stability-indicating RP - HPLC method for determination of lacosamide

Abstract

A novel stability-indicating reverse phase high pressure liquid chromatographic assay method was developed and validated for the determination of lacosamide (LCM). This method was developed based on forced degradation data obtained by HPLC analysis. Lacosamide was subjected to stress under the conditions of hydrolysis (acidic, basic and neutral), oxidation, thermal and photolysis as approved by ICH. The separation of degradation products from lacosamide was accomplished on Hypersil BDS C 18 Column using (250 × 4.6mm, 5μm) 0.01M mono basic potassium phosphate for adjusting the pH to 4.0 with orthophosphoric acid: acetonitrile (30:70, v/v) as mobile phase. The flow rate was 1.0 mL/min and the detection was carried out at 215 nm. The developed isocratic LC method was consequently validated for specificity, linearity, range, accuracy, precision and robustness. No previous reports were found in the literature regarding the degradation behavior of lacosamide.