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Development and validation of RP-HPLC method fordetermination of safinamide mesylate in bulk and in tabletdosage form.

Vivekkumar K.Redasani, Bhushan J.Mali, Amod S.Patil, Atul A.Shirkhedkar.

A rapid, highly sensitive high performance liquid chromatographic method has been developed for the determination of Safinamide mesylate in bulk drug and in tablets. Safinamidemesylate was eluted fromaNEOSPHER RP C18 reversed phase column with a mobile phase consisting ofmethanol and water (80:20, v/v) at a flow rate of 1 mL/min with UV detection at 226 nm. The retention time for Safinamidemesylatewas 5.2min. The linear response (r2 = 0.9998) was observed in the range of 5 - 30 µg/mL with limits of detection (LOD) and quantification (LOQ) being 0.27 and 0.83 µg, respectively. The method shows good recoveries and intra and inter-day relative standard deviations were less than 1.0%. Validation parameters as specificity, accuracy, ruggedness and robustness were also determined. The proposed method provides accurate and precise quality control tool for routine analysis of Safinamide mesylate in bulk and in tablet dosage form.  2013 Trade Science Inc. - INDIA.