Multidimensional evaluation of impurity profiles for generic cephalexin and cefaclor antibiotics

A multidimensional approach is described for characterizing impurities in samples of generic cefaclor and cephalexin antibiotics. High-performance liquid chromatography (HPLC) with gradient elution followed by photodiode array or mass spectrometric detection provides valuable information concerning...

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Bibliographic Details
Published in:Journal of Chromatography A 1993-10, Vol.648 (1), p.165-173
Main Authors: Olsen, B.A., Baertschi, S.W., Riggin, R.M.
Format: Article
Language:English
Subjects:
Analytical chemistry
Chemistry
Chromatographic methods and physical methods associated with chromatography
Exact sciences and technology
Other chromatographic methods
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Summary:A multidimensional approach is described for characterizing impurities in samples of generic cefaclor and cephalexin antibiotics. High-performance liquid chromatography (HPLC) with gradient elution followed by photodiode array or mass spectrometric detection provides valuable information concerning the nature of impurities observed. Results are presented which demonstrate the utility of these techniques for identifying impurities and distinguishing among process-related impurities, degradation products and formulation excipients. Preparative HPLC isolation and spectroscopic identification of some impurities is also described.
ISSN:0021-9673
DOI:10.1016/0021-9673(93)83298-7