Approach to method development and validation in capillary electrophoresis for enantiomeric purity testing of active basic pharmaceutical ingredients
A chiral capillary electrophoresis system allowing the determination of the enantiomeric purity of an investigational new drug was developed using a generic method development approach for basic analytes. The method was optimized in terms of type and concentration of both cyclodextrin (CD) and elect...
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| Veröffentlicht in: | Electrophoresis 2005-06, Vol.26 (12), p.2330-2341 |
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| creator | Sokoliess, Torsten Köller, Gerhard |
| description | A chiral capillary electrophoresis system allowing the determination of the enantiomeric purity of an investigational new drug was developed using a generic method development approach for basic analytes. The method was optimized in terms of type and concentration of both cyclodextrin (CD) and electrolyte, buffer pH, temperature, voltage, and rinsing procedure. Optimal chiral separation of the analyte was obtained using an electrolyte with 2.5% carboxymethyl‐β‐CD in 25 mM NaH2PO4 (pH 4.0). Interchanging the inlet and outlet vials after each run improved the method's precision. To assure the method's suitability for the control of enantiomeric impurities in pharmaceutical quality control, its specificity, linearity, precision, accuracy, and robustness were validated according to the requirements of the International Conference on Harmonization. The usefulness of our generic method development approach for the validation of robustness was demonstrated. |
| doi_str_mv | 10.1002/elps.200410257 |
| format | Article |
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The method was optimized in terms of type and concentration of both cyclodextrin (CD) and electrolyte, buffer pH, temperature, voltage, and rinsing procedure. Optimal chiral separation of the analyte was obtained using an electrolyte with 2.5% carboxymethyl‐β‐CD in 25 mM NaH2PO4 (pH 4.0). Interchanging the inlet and outlet vials after each run improved the method's precision. To assure the method's suitability for the control of enantiomeric impurities in pharmaceutical quality control, its specificity, linearity, precision, accuracy, and robustness were validated according to the requirements of the International Conference on Harmonization. The usefulness of our generic method development approach for the validation of robustness was demonstrated.</description><identifier>ISSN: 0173-0835</identifier><identifier>EISSN: 1522-2683</identifier><identifier>DOI: 10.1002/elps.200410257</identifier><identifier>PMID: 15920778</identifier><language>eng</language><publisher>Weinheim: WILEY-VCH Verlag</publisher><subject>beta-Cyclodextrins ; Buffers ; Capillary electrophoresis ; Cyclodextrin ; Cyclodextrins ; Electrophoresis, Capillary - methods ; Enantiomeric purity ; Hydrogen-Ion Concentration ; Pharmaceutical Preparations - isolation & purification ; Pharmaceutical Preparations - standards ; Polyvinyl Alcohol ; Reproducibility of Results ; Sensitivity and Specificity ; Stereoisomerism</subject><ispartof>Electrophoresis, 2005-06, Vol.26 (12), p.2330-2341</ispartof><rights>Copyright © 2005 WILEY‐VCH Verlag GmbH & Co. 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| fulltext | fulltext |
| identifier | ISSN: 0173-0835 |
| ispartof | Electrophoresis, 2005-06, Vol.26 (12), p.2330-2341 |
| issn | 0173-0835 1522-2683 |
| language | eng |
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| source | MEDLINE; Wiley Online Library All Journals |
| subjects | beta-Cyclodextrins Buffers Capillary electrophoresis Cyclodextrin Cyclodextrins Electrophoresis, Capillary - methods Enantiomeric purity Hydrogen-Ion Concentration Pharmaceutical Preparations - isolation & purification Pharmaceutical Preparations - standards Polyvinyl Alcohol Reproducibility of Results Sensitivity and Specificity Stereoisomerism |
| title | Approach to method development and validation in capillary electrophoresis for enantiomeric purity testing of active basic pharmaceutical ingredients |
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