title: An improved liquid chromatographic method for the analysis of tylosin and its impurities.
abstract: A selective reversed-phase (RP) liquid chromatographic (LC) method coupled with UV for the determination of tylosin and its related substances is described. The gradient method uses a Capcell pak C18 ACR column (25 cm×4.6 mm id, 5 μm) maintained at a temperature of 60°C. The mobile phases consist of acetonitrile, phosphate buffer pH 5.5 and water: (A; 27.5:10:62.5 v/v/v) and (B; 50:10:40 v/v/v). The flow rate is 1.0 mL/min and UV detection is performed at 280 nm. It allows the separation of all known and 22 other unknown related substances (≥0.02%) from the main compound and from one another. The method shows good precision, sensitivity, linearity (between 0.2 μg/mL and 1.25 mg/mL) and robustness. The limit of quantification is 0.2 μg/mL, corresponding to 0.020%. Seven bulk tylosin samples containing a large number of impurities were examined using this method.
authors.affiliation: Laboratorium voor Farmaceutische Analyse, Faculteit Farmaceutische Wetenschappen, Katholieke Universiteit Leuven, Leuven, Belgium.
authors.forename: Dunge
authors.initials: D
authors.lastname: Ashenafi
authors.forename: Jos
authors.initials: J
authors.lastname: Hoogmartens
authors.forename: Erwin
authors.initials: E
authors.lastname: Adams
mesh_terms: D000900:Anti-Bacterial Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004340:Drug Contamination; D012680:Sensitivity and Specificity; D015645:Tylosin / Q000032:analysis*
chemical_list: D000900:Anti-Bacterial Agents; D015645:Tylosin