ANALYTICAL () METHOD FOR IDENTIFYING, DOSING ENROFLOXACINE AND CHEMICALLY RELATED IMPURIITIES IN THE PHARMACEUTICAL PRODUCT ENRODEM 10 - ORAL SOLUTION, ENRODEM 50-HYDROSOLUBLE POWDER AND ENROFLOXACINE HCL AS ACTIVE PHARMACEUTICAL INGREDIENT

摘要

The invention relates to an analytical method of identifying and dosing enrofloxacine and the chemically related impurities. According to the invention, the method consists of the chromatography on an octadecylsyllyl silicagel column, at a temperature on the column of 40°C by using acetonitrile as movable phase: HPO25 mM and tetrahydrofuran, the column testing being performed by injecting a reference solution containing 3 ppm of enrofloxacine and 3 ppm of ciprofloxacine, with a concentration of 1000 ppm, at a number of minimum 2000 of theoretical plates for enrofloxacine and a resolution of minimum 1.5 between the peaks of the components, the recording time being of about 10 minutes, namely twice the enrofloxacine retention time.