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 × 4.0 mm i.d.), 5 μm kept at 40 °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.
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