Liquid chromatography method for separation of clindamycin from related substances.
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.
Orwa
J A
JA
Katholieke Universiteit Leuven, Faculteit Farmaceutische Wetenschappen, Laboratorium voor Farmaceutische Chemie en Analyse van Geneesmiddelen, Belgium.
Vandenbempt
K
K
Depuydt
S
S
Roets
E
E
Hoogmartens
J
J
D000900:Anti-Bacterial Agents / Q000032:analysis* / Q000302:isolation & purification; D002214:Capsules / Q000032:analysis; D002853:Chromatography, Liquid / Q000379:methods / Q000592:standards; D002981:Clindamycin / Q000032:analysis* / Q000302:isolation & purification; D006863:Hydrogen-Ion Concentration; D015203:Reproducibility of Results; D013329:Structure-Activity Relationship; D013696:Temperature
D000900:Anti-Bacterial Agents; D002214:Capsules; D002981:Clindamycin