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

摘要

A selective, repeatable, and robust isocratic liquid chromatographic method has been devel-oped for the analysis of bulk samples of roxithromycin, a semi-synthetic macrolide antibiotic. The method involves the use of XTerra RP18 as stationary phase and acetonitrile-2.0 M (NH_4)_2HPO_4, pH 6,4-water, 25:30:45, (v/v) as mobile phase, delivered at a flow rate of 10 mL min~(-1). Detection was by UV absorbance at 215 nm. Sufficient separation of roxithromycin from its homolog containing one more methyleneoxy group (roxithromycin G) and from other re-lated substances was achieved. The robustness of the method was evaluated by means of a full-factorial experimental design.