Development and validation of a liquid chromatographic method for the analysis of capreomycin sulfate and its related substances

A gradient LC method for the analysis of capreomycin sulfate and its related substances was developed. The chromatographic conditions include the use of a Hypersil base deactivated C18 (250 mm × 4.6 mm, 5 μm) column maintained at 25 °C, a mobile phase containing acetonitrile, phosphate buffer pH 2.3 and 0.025 M hexanesulfonate at a flow rate of 1.0 mL/min and UV detection performed at 268 nm. Good separation of the four active components of capreomycin and eleven unknown impurities was achieved. A system suitability test to check the quality of the separation is specified. The method shows good repeatability, linearity and robustness.