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Development of Polar Organic Mode Chromatographic Method by Polysaccharide-Based Immobilized Chiral Selector and Validation for the Determination of the Enantiopurity of Novel Mineralocorticoid Receptor Antagonist Atropisomer–Esaxerenone.
- Source :
- Chromatographia; Jul2022, Vol. 85 Issue 7, p553-562, 10p
- Publication Year :
- 2022
-
Abstract
- Esaxerenone is a new nonsteroidal mineralocorticoid receptor antagonist utilized to treat high blood pressure. Chemically, esaxerenone is a pyrrole derivative consisting of hindered rotation, which results in stereoisomers named atropisomers. Currently, no methods exist for the separation and quantification of these atropisomers. A new and accurate chiral liquid chromatographic technique was developed and validated to estimate the enantiomeric purity of esaxerenone. Polar organic chiral separation was carried out on an immobilized amylose-based chiral stationary phase (Chiralpak IG) with methanol:acetonitrile:diethylamine (9:1:0.1, v/v/v) mixture as a mobile phase. The total runtime was 15 min, and the resolution (R<subscript>s</subscript>) between the atropisomers was more than 3.0. The detection and quantification thresholds for the R-atropisomer were found to be 0.03 and 0.1 µg mL<superscript>−1</superscript>, respectively, for a test concentration of esaxerenone (1000 µg mL<superscript>−1</superscript>). Over the range from the limit of quantification to 0.3 percent, the method's linearity for the R-atropisomer was excellent (R<superscript>2</superscript> > 0.999). The R-atropisomer recovery varied from 95 to 102%, confirming the method's good accuracy. For a 48-h research period, the chemical was shown to be stable. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00095893
- Volume :
- 85
- Issue :
- 7
- Database :
- Complementary Index
- Journal :
- Chromatographia
- Publication Type :
- Academic Journal
- Accession number :
- 158078929
- Full Text :
- https://doi.org/10.1007/s10337-022-04164-w