Chiral Separation and Determination of Four Lurasidone Hydrochloride Enantiomers by HPLC
- VernacularTitle:HPLC法同时测定盐酸鲁拉西酮中的四种光学异构体的含量
- Author:
Ligang ZHENG
;
Xiaoxue BAI
;
Wenmin GUO
;
Manman WANG
;
Binglin WANG
;
Xuliang WANG
;
Surui CHEN
- Publication Type:Journal Article
- Keywords:
Lurasidone hydrochloride;
Enantiomers;
Determination;
Chrial separation;
HPLC
- From:
China Pharmacist
2014;(2):188-190
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish the determination method for four lurasidone hydrochloride enantiomers by HPLC. Methods:Lurasidone hydrochloride enantiomers were separated on a CHIRALPAK AD-H column (250 mm × 4. 6 mm, 5μm). The mobile phase consisted of hexane-ethanol-diethylamine ( 90∶10∶0. 1) at a flow rate of 1. 0 ml·min-1 and the column temperature was at 40℃. The detection wavelength was 230nm. Results:The resolution of lurasidone hydrochloride enantiomers was above 2. 0. The linear calibra-tion curves were obtained over the range of 5-120 μg· ml-1 for all the enantiomers (r=0. 999 9). The recovery was above 99. 0%with RSD below 0. 5%. The detection limits were 5ng. Conclusion:The method is simple, accurate and rapid, and suitable for the de-termination and quality control.