HPLC Assay and Impurity Profiling Methods for Safinamide and Safinamide Related Impurities

INTRODUCTION

A simple and accurate method was developed for purity analysis of safinamide using high-performance liquid chromatography with a diode array detector (HPLC-DAD). The method was developed for a family of safinamide compounds consisting of the active pharmaceutical ingredient safinamide and multiple corresponding impurities. This is to our knowledge the first reported method for safinamide and related impurities. Safinamide free acid, safinamide mesylate, safinamide defluor-derivative, and safinamide imidazolidinone can be resolved in a 20-minute method using an Ascentis^® Express C8 column (150 x 4.6 mm, 5 μm). A gradient that utilized 0.1% trifluoroacetic acid in water and acetonitrile was employed. Under the applied conditions the system suitability criteria are met. The method demonstrates good resolution and selectivity, reproducibility, and sensitivity.

EXPERIMENTAL CONDITIONS

Results

Chromatographic Data - Specificity (Resolution Solution)

Linearity - Calibration

CONCLUSION

A new method was developed for analyzing the purity of safinamide and its related compounds using high-performance liquid chromatography with a diode array detector. The method uses an Ascentis^® Express C8 HPLC column and a gradient of 0.1% trifluoroacetic acid in water and acetonitrile and takes 20 minutes to resolve the compounds. The method is reproducible and sensitive and shows good resolution and selectivity.

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