Development and Validation of an RP-HPLC Method for the determination of Safinamide Mesylate in Bulk and Pharmaceutical Dosage Form

Abstract

A rapid and highly sensitive high performance liquid chromatographic method has been developed for the determination of Safinamide Mesylate in bulk and in tablet dosage form. Safinamide mesylate was eluted from a XBridge C18 (250mmX4.6mm) reversed phase column with a mobile phase of Ammonium acetate buffer pH 5.8 and Acetonitrile in the ratio of 55:45 (v/v) at a flow rate of 1ml/min with UV detection of 26nm. The retention time for Safinamide mesylate was 3.8min. The linear response (r2 = 0.997) was observed in the range of 10-60 µg/ml with limits of detection (LOD) and quantification (LOQ) being 2.85 and 9.5µg/ml respectively. The method shows good recoveries and intra and inter-day relative standard deviations were less than 2%. Validation parameters as Specificity, accuracy, ruggedness and robustness were also determined. The proposed method provides accurate and precise quality control tool for routine of Safinamide mesylate in bulk and in tablet dosage form.