RESUMEN
Objective:To establish a method for the determination of sodion in cefalotin sodium by ion chromatography and investi-gate the salt-forming rate of the products. Methods: A TSKgelSuper IC-CR cation exchange column (150 mm × 4. 6 mm, 3. 0 μm) was used. The mobile phase was the mixture of 2. 2 mmol·L-1 methanesulfonic acid and 1 mmol·L-1 18-crown-6-ether with the flow rate of 0. 8 ml·min-1 . The column temperature was 40℃ and the injection volume was 20μl. The detector was an electric conductiv-ity detector. Results:The linear correlation of sodion was good within the range of 3. 0-60. 0μg·ml-1(r=0. 999 9). The average re-covery was 99. 8%(RSD=0. 8%, n=9). The mole number ratio of sodion to cefalotin was within the range of 0. 97-1. 03. Conclu-sion:The method is specific, precise and accurate, and can be used in the determination of sodion in cefalotin sodium. The salt-form-ing rate of the 8 batches of samples is promising.
RESUMEN
OBJECTIVE:To establish a method for test of bacterial endotoxin on cefalotin sodium for injection by gel clot.METHODS:Cefalotin sodium for injection was diluted in water for determination of bacterial endotoxin and allocated to sample negative and sample positive controls to determine its maximum noninterference concentration;Then bacterial endotoxins were diluted into solutions of different concentrations with the test solutions,and interference test was carried out by using tachy?pleus amebocyte lysate sensitivity compound nucleus.RESULTS:The maximum noninterference concentration of cefalotin sodium for injection was6.68mg/ml;And cefalotin sodium at the concentration of1.67mg/ml did not interfere with the test for bacterial endotoxins.CONCLUSION:The present method can replace pyrogen test with rabbit for examination of bacterial endotoxin in cefalotin sodium for injection.
RESUMEN
OBJECTIVE:To establish HPLC method in the determination of the related substances in cefalotin sodium.METHODS:The determination was performed with C 18 as the chromatographic column.The mobile phase was consisted of sodium acetate solution-acetonitrile(82∶18)with a flow rate at1.0ml/min.The column temperature was30℃and the detection wavelength was254nm.RESULTS:All the chief peaks of cefalotin sodium and those of their related substances could be well isolated in all the specificity tests.The total peak area of the chief foreign substances of all the3batches of samples were no more than the twice of the chief peak area of their control solutions.CONCLUSION:This method is simple,accurate and reproducible.