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-1H-isoindol-2-yl)-N-(1,3-thiazol-2-yl)acetamide (EAI045). The enantiomers of EAI045 were baseline resolved on a Chiralpak AD-H (250mm×4.6mm, 5μm) column using a mobile phase system containing n-hexane: 2-propanol (75: 25v/v) at a flow rate of 1mLmin-1 at 30°C. The eluted analytes were subsequently detected with an ultraviolet detector at 254nm. 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 600μgmL-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 3.07μgmL-1 and for S-enantiomer were 0.86 and 2.84μgmL-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.
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