title: Liquid chromatographic analysis of oxytocin and its related substances.
abstract: A selective gradient liquid chromatographic (LC) method for the determination of oxytocin (OT) and its related substances in bulk drugs has been developed. The method uses a reversed-phase C18 column (25 cm x 4.0 mm i.d.), 5 microm kept at 40 degrees C. The mobile phases consist of acetonitrile, dihydrogen phosphate solution pH 4.4 and water. The flow rate is 1.0 ml/min. UV detection is performed at 220 nm. A system suitability test (SST) was developed to govern the quality of the separation. The separation towards OT components was investigated on different C18 columns. The developed method was further validated with respect to robustness, precision, sensitivity and linearity. A central composite design was applied to examine the robustness of the method. The method shows good precision, sensitivity, linearity and robustness. Two commercial OT samples were examined using this method. Furthermore, the method proved to be successful when applied to analyze a marketed OT formulation for injection.
authors.affiliation: Faculteit Farmaceutische Wetenschappen, Katholieke Universiteit Leuven, Leuven, Belgium.
authors.forename: Dunge
authors.initials: D
authors.lastname: Ashenafi
authors.forename: Elise
authors.initials: E
authors.lastname: Van Hemelrijck
authors.forename: Shruti
authors.initials: S
authors.lastname: Chopra
authors.forename: Jos
authors.initials: J
authors.lastname: Hoogmartens
authors.forename: Erwin
authors.initials: E
authors.lastname: Adams
mesh_terms: D002853:Chromatography, Liquid / Q000379:methods*; D004340:Drug Contamination; D007267:Injections; D010120:Oxytocics / Q000032:analysis*; D010121:Oxytocin / Q000032:analysis*; D015203:Reproducibility of Results
chemical_list: D010120:Oxytocics; D010121:Oxytocin