Abstract:

Acetylspiramycin (ASPM), a 16-membered basic macrolide antibiotic, is the acetylated derivative of spiramycin. In addition to the four main components, more than seventy minor components could be present in ASPM. Thus, it is a challenge to obtain a baseline separation of ASPM components. Meanwhile, in some cases it was found that the results obtained by different brands of C18 columns were significantly different, indicating the necessity of a rational column selection for the separation of ASPM components. In this paper, we attempted to facilitate column selection for the analysis of ASPM using the database of the column characterization system established by Leuven University. With the CAPCELL PAK MG C18 (250 mm×4.6 mm, 5 µm) as the reference column, three groups of columns (F<2 group: similar selectivity; 2<F<6: intermediate ranked group; F>6 group: different selectivity, compared to the reference column) were selected, and their performances in the separation of ASPM components were evaluated under the chromatographic conditions described in Chinese Pharmacopoeia monograph. A good relationship was demonstrated between the ranking of columns and their selectivity in the separation of ASPM components, indicating the column classification system established by Leuven University was a helpful tool in the selection of suitable columns for the analysis of ASPM, a complex mixture of basic compounds.

Key words: Acetylspiramycin, Semi-synthetic antibiotic, Column selection, Column characterization system,