Quantitative Method for the Bacterial Endotoxin in Aminoglycoside Antibiotics for Injection / 中国药房

ABSTRACT

OBJECTIVE: To establish a method for endotoxin assay in aminoglycoside antibiotics for injection.METHODS: Kinetic turbidimetric limulus test was used for endotoxin assay in aminoglycoside antibiotics for injection.The recovery rate of bacterial endotoxin was determined though pre-interference experiments in which quantitative endotoxin was added to different concentrations of aminoglycosides with the concentration optimized,then an interference test on 4 different samples was conducted.RESULTS: At a concentration of 0.5 mg?mL-1,aminoglycosides didn't interfere with the limulus test if the amount of standard endotoxin was at 5.000,0.500,and 0.050 EU?mL-1,respectively.CONCLUSIONS: The kinetic turbidimetric limulus test could be used for endotoxin assay in aminoglycoside antibiotics for injection.