Application Of Liquid Chromatography With Tandem Mass Spectrometric Method For Quantification Of Safinamide In Invitro Samples

Pharmaceutical Science-Pharmaceutical analysis for Novel drug formulation

Abstract

Safinamide is a novel drug with both dopaminergic and non-dopaminergic effects, approved first by the European Commission   and   more   recently   by   the   US   Food   and   Drug   Administration   (FDA)   as   an   adjunctive treatment   to carbidopa/levodopa in patients with mid- to late-stage Parkinson’s disease (PD) and motor fluctuations. The validated analytical method was applied for the estimation of Safinamide in aqueous solution and human plasma with Safinamide-D4 as an internal standard by using UPLC-MS/MS. The chromatographic separation was achieved with 0.1% formic acid solution: Methanol, 30:70% v/v using CORTECS C18 with 100 x 4.6, 2.7 µ. The total analysis time was 4 min, and the flow rate set to 0.8 mL/min. The mass transitions of Safinamide and Safinamide-D4 obtained were m/z 303.3 and 215.2 and 307.3 and 215.2.  The standard curve shows a correlation  coefficient  (r2) greater  than 0.998 with a range of 113.0-338.0  pg/mL  using the linear regression  model. The method has shown good reproducibility, as intra- and interday precisions were within 10% and accuracies were within 8% of nominal values for both analytes. The method was successfully applied for the forced degradation studies at various stress conditions.