Published:Journal of Chromatographic Science,
ISSN 0021-9665Volume 40, Number 9, October 2002, pp. 529-533
Isocratic Liquid Chromatographic Method for the Analysis of Azithromycin
and Its Structurally Related Substances in Bulk Samples
F.N. Kamau, H.K. Chepkwony, J.K. Ngugi, D. Debremaeker, E. Roets,
and J. Hoogmartens*
Laboratorium voor Farmaceutische Chemie en Analyse van Geneesmiddelen, Faculteit
Farmaceutische Wetenschappen, Katholieke Universiteit Leuven, Van Evenstraat
4, 3000 Leuven, Belgium
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.
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