期刊
CHROMATOGRAPHIA
卷 83, 期 7, 页码 909-913出版社
SPRINGER HEIDELBERG
DOI: 10.1007/s10337-020-03911-1
关键词
Sunosi(R); Chiral separation; Polar organic mode; Enantioselective HPLC; Polysaccharide-type chiral stationary phase
Solriamfetol is a novel FDA approved enantiopure drug used for the treatment of excessive sleepiness associated with narcolepsy or obstructive sleep apnea. Only the activeR-enantiomer is marketed, therefore, a method to determine the chiral purity is essential. Chiral separation of solriamfetol was performed by HPLC using polysaccharide-type chiral stationary phases in polar organic mode and described for the first time. Seven different polysaccharide-based chiral columns (Lux Amylose-1, Lux i-Amylose-1, Lux Amylose-2, Lux Cellulose-1, Lux Cellulose-2, Lux Cellulose-3 and Lux Cellulose-4) were employed for the separation of enantiomers using polar organic mode, with mobile phases consisting of 0.15% diethylamine in methanol (MeOH), 2-propanol (IPA) or acetonitrile (ACN). During the screening phase, the best results (R-s> 5, in less than 10 min) was obtained on a Lux Amylose-1 column with 0.15% diethylamine in methanol with an ideal elution order (the distomer eluted before theR-enantiomer). The effects of binary mobile phases on the resolutions and retention factors were also investigated containing different percentages of MeOH:ACN and MeOH:IPA. Using optimized parameters (Lux Amylose-1 column with 0.05% diethylamine in MeOH with 0.6 mL/min flow rate at 20 degrees C) high enantioresolution (R-s = 5.3) was achieved within 6 min. Thermodynamic analysis was performed and revealed an enthalpy-driven enantioseparation. The developed, isocratic HPLC method was validated according to current ICH guidelines and proved to be reliable, linear, precise and accurate for the determination of 0.1%S-enantiomer as a chiral impurity inR-solriamfetol.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据