ANALYTICAL () METHOD FOR IDENTIFYING, DOSING FLUORFENICOL AND THE CHEMICALLY RELATED IMPURITIES IN THE PHARMACEUTICAL PRODUCTS FLUORFENIDEM 10-ORAL SOLUTION, FLUORFENIDEM 50 AND FLUORFENICOL ASACTIVE PHARMACEUTICAL INGREDIENT

摘要

The invention relates to an analytical method for identifying and dosing florfenicol and the related chemical impurities in the pharmaceutical products containing this active ingredient. According to the invention, the method comprises a HPLC chromatography by using a octadecylsillyl silicagel for R chromatography, with the length of 150 mm, the inside diameter of 4.6 mm, particle size of 5 μ m, at a column temperature of 25°C, with isocratic eluation, the composition of the movable phase being Solvent A: Solvent B 60:40 v/v, where the Solvent A is HPLC water and Solvent B is acetonitrile R, with a flow rate of the movable phase of 1ml/minute, with UV detection at the length of 254 nm, column in which there are injected 10 μ m of reference solution a, containing 5000 ppm of florfenicol, this solution also representing the solution for testing the chromatographic system, on the condition of the existence of at least 500 theoretical plates for the peak of florfenicol.