Author:

Keywords:

Science & Technology, Physical Sciences, Life Sciences & Biomedicine, Chemistry, Analytical, Pharmacology & Pharmacy, Chemistry, Spiramycin, Impurity characterization, Core-shell particle, Liquid chromatography, TRAP MASS-SPECTROMETRY, IMPURITIES, IDENTIFICATION, VALIDATION, EFFICIENCY, TYLOSIN, COLUMN, MS/MS, HPLC, Acetonitriles, Chemistry, Pharmaceutical, Chromatography, High Pressure Liquid, Drug Contamination, Porosity, Quality Control, Reference Standards, Tandem Mass Spectrometry, Time Factors, 0301 Analytical Chemistry, 1115 Pharmacology and Pharmaceutical Sciences, Analytical Chemistry, 3214 Pharmacology and pharmaceutical sciences, 3401 Analytical chemistry

Abstract:

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 (0.2M; 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 232nm. 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).