Safinamide Mesylate: Analytical and Chromatographic Methodologies

Safinamide Mesylate (SAF) (S1), also known as (S)-2-(4-((3-Fluorobenzyl) oxy) benzyl) amino) propanamide methane sulfonate, is a recently developed medicine to treat Parkinson’s disease (PD). Safinamide is a third-generation reversible MAO-B inhibitor, which also blocks sodium voltage-sensitive channels and modulates stimulated release of glutamate. Safinamide used to supplement levodopa/carbidopa for Parkinson’s disease therapy during "off" episodes. According to the literature, there are many methods for the analysis of Safinamide Mesylate, so we gather all methods in one review. Safinamide was monitored using High Performance liquid Chromatography (HPLC), High Performance Thin Layer Chromatography (HPTLC), and Bio analytical Method Development of Safinamide by UPLC-MS/MS, and RP-HPLC, Stability Indicating assay method for development and validation. The primary focus is on chromatographic methods, particularly High-Performance liquid Chromatography (HPLC), which remains the most preferred approach due to its robustness, accuracy and precision. Several key factors involved in method development, including column type, detection wavelength, and mobile phase compositions are discussed in details. Furthermore, critical validation parameters, such as linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), are examined in accordance with the guidelines set by the international council for harmonization (ICH) and other regulatory authorities.