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 C(18) (250 mm x 4.6mm, 5 microm) column maintained at 25 degrees C, a mobile phase containing acetonitrile, phosphate buffer pH 2.3 and 0.025M 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.
Mallampati
Swapna
S
Laboratory for Pharmaceutical Analysis, KU.Leuven, O&N II, Leuven, Belgium.
Huang
Shan
S
Ashenafi
Dunge
D
Van Hemelrijck
Elise
E
Hoogmartens
Jos
J
Adams
Erwin
E
D000900:Anti-Bacterial Agents / Q000032:analysis*; D002207:Capreomycin / Q000032:analysis*; D002853:Chromatography, Liquid / Q000379:methods*; D004340:Drug Contamination; D004355:Drug Stability; D006861:Hydrogen Peroxide / Q000737:chemistry; D006868:Hydrolysis; D016018:Least-Squares Analysis; D016014:Linear Models; D008956:Models, Chemical; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013696:Temperature
D000900:Anti-Bacterial Agents; D002207:Capreomycin; D006861:Hydrogen Peroxide