Analytical Method Development and Validation for Estimation of Safinamide Mesylate by RP-HPLC in Bulk Drug and Pharmaceutical Dosage Form

A new, accurate and precise High performance liquid chromatography method have been developed for the estimation of Safinamide Mesylate in bulk drug and pharmaceutical dosage form. The chromatographic separation was carried out on Agilent poroshell C18 (150 mm X 4.6 mm i.d.) 5μm column using a mixture of Acetonitrile: 0.1% TFAA in Water (70:30) as a mobile phase at a flow rate of 1.0 ml/min, the detection as carried out at 226 nm. The retention time of Safinamide Mesylate was 2.63 respectively. The method produced linear responses in the concentration range of 15.0 -45.0 μg/ml of Safinamide Mesylate. The LOD and LOQ was found to be LOD = 0.259 μg/mL and LOQ = 0.785 μg/mL for Safinamide Mesylate respectively. The accuracy of method was validated by recovery studies and found to be significant within acceptable range 98.0-102.0%. The developed RP-HPLC method is found to be accurate, precise, linear and robust. The present work is successfully developed and validated as per ICH guidelines. The proposed method provides accurate and precise quality control tool for routine of Safinamide Mesylate in bulk and in pharmaceutical dosage form.