International Journal of Life science and Pharma Reviews (IJLPR)  
  Aim and Scope - To publish peer reviewed review articles in rapidly developing field of Pharma and life sciences  
Pharmaceutical Sciences
Volume 10 issue 2, April - June 2020    Pages:55-61
Application of Liquid Chromatography with Tandem Mass Spectrometric Method for Quantification of Safinamide in Invitro Samples

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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 ¬Ķ. 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.
Keywords: Safinamide; human plasma; aqueous; bioanalysis; method validation.
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