ABSTRACT
Parkinson's disease (PD) is the second most common chronic progressive neurodegenerative disorder in the elderly after Alzheimer' 8 disease. Over the decadcs, levodopa has been considered the main therapy against PD. However, long term use of levodopa is often accompanicd by adverse reactions, including nausea, insomnia, dyskinesia, and "wetring-off" and " on-o/T" phenomena, ranging in severity from mild and non-disabling to incapacitating. On March 21 2017, US Food and Drug Administration ( FDA ) approved safinamide us an adjunctive treatment to levodopa in patients vilh PD experiencing " off" episodes. As a new drug for the treatment of PD, safinamide has the advantage of high selectivity and safely. This paper reviews the mechanisms and some clinical trials of safinamide.
ABSTRACT
Objective: To establish a determination method for the enantiomer in safinamide mesilate. Methods: A Chiralpak ASH (250 mm ×4. 6 mm, 5 μm) column was used with the mobile phase of n-hexane-ethanol-diethylamine (75 ∶ 25 ∶ 0. 1). The flow rate was 1. 0 ml·min-1 . The wavelength was set at 225 nm. The column temperature was 35℃. Results: The resolution of safinamide mesilate and the enantiomer was above 2. 0. The linear range of them was 1. 007-2 517. 500 μg·ml-1 and 0. 909-2273. 200 μg·ml-1 ,respectively(r = 0. 999 0). The average recovery of the enantionmer was 104. 9% with RSD of 2. 3% (n = 9). Conclusion: The method is accurate and rapid, and suitable for the determination of the enantiomer in safinamide mesilate.