Development And Validation Of RP-HPLC Method For Determination of Safinamide Mesylate And Nasal Spray Formulation

Abstract

A highly precise, sensitive, accurate, and rapid isocratic reverse phase high-performance liquid chromatography (RP-HPLC) method has been developed for the determination of safinamide mesylate, a selective monoamine oxidase B (MAO-B) inhibitor used in the treatment of Parkinson's disease, in bulk drug material. The method was validated according to ICH specifications. The separation using chromatography was performed isocratically on a C18 column (5µm, 4.6 x 250mm) at room temperature, utilizing an elution solvent composed of ethyl nitrile and monobasic potassium phosphate buffer, with a flow rate of 0.6 ml/min and UV detection set at 226 nm. Safinamide mesylate demonstrated linearity (R² = 0.9939) across a specified concentration range 2-10 µg/ml, with a limit of detection (LOD) and limits of quantification (LOQ) measured to be of 1.736 and 5.789 μg/ ml respectively. The method demonstrated an accuracy of 83.74%-88.76%. The relative standard deviations for intra-day and inter-day precision were under 0.5%. Nasal spray formulations SP1NF containing PLGA nano particles safinamide mesylate and SC1NF chitosan nanoparticles safinamide mesylate was developed using emulsion solvent evaporation method and ionic gelation method respectively. Using RP-HPLC validated analytical method, concentration of standard drug and nasal spray formulations was found to be 97.93%, 85.23% and 98.96% respectively. The validated method showcased remarkably selective, precise, linear and highly sensitive outcomes, making it suitable for developing the assay of safinamide mesylate API and nasal spray formulation.