Determination of the Enantiomer in Safinamide Mesilate by HPLC
- VernacularTitle:HPLC法测定甲磺酸沙芬酰胺中对映异构体的含量
- Author:
Qi ZHANG
;
Qianru ZHANG
;
Jingyuan LIU
;
Wenmin GUO
- Publication Type:Journal Article
- Keywords:
Safinamide mesilate;
Enantiomer;
HPLC;
Determination
- From:
China Pharmacist
2016;19(3):582-584
- CountryChina
- Language:Chinese
-
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.
