RP-HPLC Method Development and Validation for Determination of Safinamide in Bulk and Pharmaceutical Formulation

<p><span lang="EN">A quick, exceedingly sensitive reverse phase high performance liquid chromatographic method has been developed and validated for the estimation of Safinamide in bulk drug and tablets. Chromatography was carried out on a (Fortis) C18 column (4.6mm x 100mm, 2.5µm) using a mixture of Acetonitrile: 0.1% OPA in the ratio of 95:05 % v/v as the mobile phase by the side of 1.0 ml/min flow rate, the detection wavelength was tired at 225 nm. The retention time of the Safinamide was 4.444 min correspondingly. The detection concentration was linear over 10-50 μg/ml for Safinamide. Regression equations of Safinamide were found to be y = 46.16 x + 4.91 with correlation co-efficient (R2) 0.999. The % RSD for Intra and Inter day precision was < 2%. The accuracy of method was validated disbursing recovery studies and found to be substantial in suitable range 98-102%. The LOD (detection limits) and LOQ (quantification limits) being 0.03046 ug/mL and 0.09230 ug/mL respectively. The developed method was positively validated in accordance with ICH guidelines and found to be accurate, precise, linear, and robust and was efficacious applied to a pharmaceutical tablet formulation for qualitative determination of Safinamide in bulk form and marketed pharmaceutical dosage forms. Hence, this proposed technique can be suitably adopted for routine analysis in quality control laboratories.</span></p>