A Quantitative Reliable RP-HPLC Method Development and Validation for the Monitoring of Acetic Acid in Lacosamide Anti Epilepsy Drug

Abstract

Lacosamide is prescribed as a partial-onset seizure medication and as an adjuvant for the treatment of primary generalized tonic-clonic seizures. A validated reverse phase HPLC method has been developed and validated to determine the acetic acid content of Lacosamide in a simple, precise, affordable, and accurate manner. There is a daily intake limit for acetic acid, which is classified as a Class III solvent under ICH recommendations. By monitoring of acetic acid in Lacosamide using this method, the final chromatographic conditions were obtained using a Kromasil-C18 (250 x 4.6mm, 5µm) and a mobile phase that was prepared by orthophosphoric acid buffer (1.0 ml of orthophosphoric acid dissolved in 1 liter of HPLC grade water) and acetonitrile. At a flow rate of 1.0 mL/min and a detection wavelength of 210 nm, a tiny runtime was achieved within 30.0 minutes. With a linear regression curve (R² = 0.99), the linearity was demonstrated in the range of 0.025–7.5mg/mL of working concentration, with limits of detection (LOD) and quantitation (LOQ) of 8.2ppm and 24.9ppm, respectively. The suggested approach was simple, sensitive, and capable of directly analyzing the amount of acetic acid without the need for a reaction.