Isocratic Liquid Chromatographic Method for the Analysis of Azithromycin and Its Structurally Related Substances in Bulk Samples

An isocratic liquid chromatographic method with UV detection at 215 nm, which is suitable for the analysis of azithromycin (AZT) in bulk samples, is described. AZT is separated from its synthesis intermediates and a degradation product as well as from six unknown impurities on an XTerra RP18 column...

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Veröffentlicht in:	Journal of chromatographic science 2002-10, Vol.40 (9), p.529-533
Hauptverfasser:	Kamau, F.N., Chepkwony, H.K., Ngugi, J.K., Debremaeker, D., Roets, E., Hoogmartens, J.
Format:	Artikel
Sprache:	eng
Schlagworte:	Analysis Anti-Bacterial Agents - analysis Azithromycin - analysis Biological and medical sciences Chromatography, Liquid - methods General pharmacology Medical sciences Pharmacology. Drug treatments Reproducibility of Results Sensitivity and Specificity Spectrophotometry, Ultraviolet
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Beschreibung
Zusammenfassung:	An isocratic liquid chromatographic method with UV detection at 215 nm, which is suitable for the analysis of azithromycin (AZT) in bulk samples, is described. AZT is separated from its synthesis intermediates and a degradation product as well as from six unknown impurities on an XTerra RP18 column at 70°C using a mobile phase consisting of acetonitrile-pH 6.5 0.2M K2HPO4-water (35:10:55, v/v/v) at 1.0 mL/min. The XTerra stationary phase contains methyl groups that are incorporated in the bulk structure of the material. This allows for special selectivities. Robustness is evaluated by a full factorial design experiment. The method shows good selectivity, repeatability, linearity, and sensitivity.
ISSN:	0021-9665 1945-239X
DOI:	10.1093/chromsci/40.9.529