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Keywords:

Anti-Bacterial Agents, Capsules, Chromatography, Liquid, Clindamycin, Hydrogen-Ion Concentration, Reproducibility of Results, Structure-Activity Relationship, Temperature, Science & Technology, Physical Sciences, Life Sciences & Biomedicine, Chemistry, Analytical, Pharmacology & Pharmacy, Chemistry, clindamycin, lincomycin, reversed-phase liquid chromatography, 0301 Analytical Chemistry, 1115 Pharmacology and Pharmaceutical Sciences, Analytical Chemistry, 3214 Pharmacology and pharmaceutical sciences, 3401 Analytical chemistry

Abstract:

A reversed-phase liquid chromatography method has been developed for the separation of clindamycin from 7-epiclindamycin, clindamycin B, lincomycin, lincomycin B, 7-epilincomycin and other impurities of unknown identity. The method uses a Hypersil ODS, 5 microm, 250 x 4.6 mm i.d. column maintained at 45 degrees C. The mobile phase comprises acetonitrile phosphate buffer (1.35% v/v phosphoric acid, adjusted to pH 6.0 with ammonium hydroxide)-water (35:40:25, v/v) at a flow rate of 1.0 ml/min. UV detection is performed at 210 nm. The method was tested on several C-18 columns and showed good robustness. Robustness was further evaluated by performing a full-fraction factorial design experiment. The method showed good selectivity, linearity, and repeatability. It is also suitable for analysis of clindamycin formulations.