A Validated LC Method for the Enantiomeric Separation of EAI045 on Chiral Stationary Phase. (18th April 2020)

• Record Type: Journal Article
• Authors: Wu, Xiuli; Zhang, Yange; Li, Wenzhen; Liu, Tingmei; Yang, Yu; Wang, Yijie; Zhang, Yiwen
• Is Part Of: Journal of chromatographic science. Volume 58:Number 6(2020)
• Page Start: 562
• Page End: 568
• Publication Date: 2020-04-18
• Subjects: Chromatographic analysis -- Periodicals; 543.8
• DOI: 10.1093/chromsci/bmz125
• Languages: English
• ISSNs: 0021-9665

Abstract

Abstract: A simple and accurate chiral liquid chromatographic method was developed for enantiomeric resolution and determination of 2-(5-fluoro-2-hydroxyphenyl)-2-(1-oxo-2, 3-dihydro-1 H -isoindol-2-yl)- N -(1, 3-thiazol-2-yl)acetamide (EAI045). The enantiomers of EAI045 were baseline resolved on a Chiralpak AD-H (250 mm × 4.6 mm, 5 μm) column using a mobile phase system containing n -hexane: 2-propanol (75: 25 v/v ) at a flow rate of 1 mL min −1 at 30°C. The eluted analytes were subsequently detected with an ultraviolet detector at 254 nm. The effects of organic modifiers and temperature on the enantioselectivity and resolution of the enantiomers were evaluated. The calibration curves were plotted within the concentration range between 2 and 600 μg mL −1 ( n = 11), and recoveries between 98.74% and 101.52% were obtained, with relative standard deviation < 1.4%. The limit of detection and limit of quantitation for R -enantiomer were 0.94 and 3.07 μg mL −1 and for S -enantiomer were 0.86 and 2.84 μg mL −1, respectively. The validated method was found to be suitable for enantiomeric separation and sufficiently accurate for the determination of enantiomeric purity of EAI045 in bulk drugs.