摘要
目的:建立测定甲磺酸沙芬酰胺中对映异构体含量的方法。方法:采用HPLC法,色谱柱:Chiralpak AS-H柱(250mm×4.6 mm,5μm);流动相:正己烷-乙醇-二乙胺(75∶25∶0.1);流速:1.0 ml·min^(-1);检测波长:225 nm;柱温:35℃。结果:甲磺酸沙芬酰胺与其对映异构体之间的分离度大于2.0;两者分别在1.007~2517.500μg·ml^(-1)和0.909~2273.200μg·ml^(-1)范围内呈良好的线性关系,r均为0.999 0;对映异构体的平均加样回收率为104.9%,RSD为2.3%(n=9)。结论:该方法准确、快速,可用于甲磺酸沙芬酰胺产品中对映异构体的含量测定。
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. 200μg·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.
出处
《中国药师》
CAS
2016年第3期582-584,共3页
China Pharmacist
基金
科技部"十二五"重大新药创制项目(编号:2014ZX09507001)
