Development and Validation of Stability-Indicating High-Performance Liquid Chromatography Method for Estimation of Lacosamide in Bulk and Its Pharmaceutical Dosage Form.

A simple, specific, accurate and stability-indicating reversed-phase high-performance liquid chromatographic method was developed for the determination of lacosamide, using C18 column and a mobile phase composed of phosphate buffer (pH 4.0):acetonitrile (40:60 v/v). The retention time of lacosamide was found to be 2.7 min. Linearity was established for lacosamide in the range of 10-50 µg/mL. The percentage recovery of lacosamide was found to be in the range of 97.37-99.20%. The drug was subjected to acid, alkali, oxidation, dry heat and photolytic degradation. The degradation studies indicated condition was well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for quantitative analysis of lacosamide in bulk drug and formulation.