Quantitative 1H NMR method for the routine spectroscopic determination of enantiomeric purity of active pharmaceutical ingredients fenfluramine, sertraline, and paroxetine
Copyright (c) 2005 John Wiley & Sons, Ltd.
| Publié dans: | Magnetic resonance in chemistry : MRC. - 1985. - 43(2005), 11 vom: 12. Nov., Seite 910-7 |
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| Format: | Article |
| Langue: | English |
| Publié: |
2005
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| Accès à la collection: | Magnetic resonance in chemistry : MRC |
| Sujets: | Journal Article Protons Fenfluramine 2DS058H2CF Paroxetine 41VRH5220H Sertraline QUC7NX6WMB |
| Résumé: | Copyright (c) 2005 John Wiley & Sons, Ltd. Determining the enantiomeric purity of chiral therapeutic agents is important in the development of active pharmaceutical ingredients (API). A strategy for determining the enantiomeric purity of three APIs was developed using nuclear magnetic resonance (NMR) and the chiral solvating agent (CSA) 1,1-bi-2-naphthyl (1). While chiral chromatography is widely used to evaluate enantiomeric purity, it can sometimes suffer from tedious sample preparation obviating rapid measurements that are sometimes needed during the manufacture of such agents. The techniques described herein provide comparable enantiomeric purity results with those obtained with traditional chiral HPLC and other published methods for these compounds. Chiral analysis of standard samples of methylbenzylamine enantiomeric mixtures using 1 were found to be quantitative to approximately 1% minor enantiomer. Enantiomeric purity determination by NMR utilizing chiral solvating agents do not require special instrumental techniques, chemical derivatization or standards and is therefore ideally suited for rapid routine analysis. As a result, the technique demonstrated is commonly used in our laboratory as a complementary or alternative method to chiral HPLC or optical rotation measurements for routine determination of enantiomeric purity |
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| Description: | Date Completed 16.02.2006 Date Revised 21.11.2013 published: Print Citation Status MEDLINE |
| ISSN: | 0749-1581 |