QbD Based Rp-Hplc Method Development And Validation for The Estimation Of Safinamide In Bulk And It’s Dosage form

Abstract

A simple and selective HPLC method is described for the determination of Safinamide by QbDChromatographic separation was achieved on a Zorbax C18 (150mm×.4.6mm & 5µm) usingmobile phase consisting of a mixture of pH 2.3 Buffer: Acetonitrile (64:34) with detection of226nm Linearity was observed in the range 50-150 µg /ml for Safinamide (r² =0.9997) for drugsestimated by the proposed methods was in good agreement with.3 the label claim. Thus, The RP-HPLC assay method developed for Safinamide by QbD approach is linear, accurate, precise,reproducible, and specific as evident from the validation results. The developed method is alsostability indicating and can be conveniently used for quality control to determine the assay inregular Safinamide product development, production, and stability samples.A new ReversePhase-HPLC method was developed for safinamide using Design Expert 9 software. In thissoftware, 3² factorial statistical designs were used to optimize the Critical Process Parameters orCritical Method Parameters and to evaluate interaction effects of these parameters on the CriticalQualityAttributes.