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Development and Validation of RP-HPLC Method for Estimation Safinamide in Its Bulk and Tablet Dosage Form

Pranali C. Baviskar, R. S. Bachhav


Background: This study developed and validated a new, sensitive, appropriate, clear, accurate, and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for determining safinamide in bulk medication and tablet formulations. An HPLC method using a UV detector and the Openlab EZchrome workstation programme, as well as a Kromasil C18 (250 mm × 4.6 mm i.d.) 5 m, were used to separate the samples. At a flow rate of 1.0 mL/min, methanol and buffer (70:30 percent v/v) were pumped and measured at 226 nm. Result: The devised RP-HPLC method gave a satisfactory safinamide retention duration of 2.57 minutes, which was refined by trial and error. A correlation value (r2) of 0.99996 was used to confirm the linearity of the established method throughout a concentration range of 1.01–15.14 g/mL. The precision of the approach was determined to have a percentage RSD of less than 2.0 percent. The percentage recoveries were found to range between 99.60 and 100.80%. The LOD and LOQ were found to be 0.17 ug/mL and 0.52 ug/mL, respectively. Conclusion: The designed and validated RP-HPLC technology saves time and can be utilised in the industry for routine quality control and analysis of bulk drugs and commercialised safinamide products.


RP-HPLC, Safinamide, Parkinson’s disease, Development, Validation

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