A novel gradient reverse phase HPLC method has been developed for quantitative estimation of Lacosamide impurities in pharmaceutical dosage form. Chromatographic separation was achieved on Waters Symmetry C8, 250 x 4.6mm, 5μ. Detection wavelength was set at 210 nm. Drug product was subjected for stress conditions of Acid, Alkali and Peroxide degradation. Lacosamide was found to be degrading significantly in Acid and alkali conditions. Peak purity of Lacosamide was found to be passing, indicates that all degradents are separated from the analyte peaks. The developed method was validated as per ICH guidelines with respect to Specificity, Linearity, Accuracy, Precision, Limit of quantification, Robustness and solution stability.
