Improved liquid chromatographic method for quality control of spiramycin using superficially porous particles


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Abstract

Graphical abstractHighlightsEasy-to-use and fast LC method for quality control of spiramycin was developed.Improved separation compared to previously published methods.A strategy using MS to profile impurities from non-volatile LC system was applied.Structures of unknown impurities were proposed based on fragmentation data.This article describes the development and validation of a liquid chromatographic method for spiramycin using a column with superficially porous particles. Gradient elution was applied and the mobile phase consisted of phosphate buffer (0.2 M; pH 8.3) – H2O – acetonitrile in a ratio 10:60:30 (v/v/v) for mobile phase A and 10:30:60 (v/v/v) for mobile phase B. UV detection was performed at 232 nm. Compared to previous methods, the analysis time was about two times faster and impurities were better separated. Furthermore, impurities which were present above 0.25% were characterized using liquid chromatography coupled with mass spectrometry (LC/MS).

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