The invention provides a method for improving the purity of a
levofloxacin product, which comprises the following steps: carrying out
condensation reaction on
levofloxacin carboxylic acid,
dimethyl sulfoxide and N-methyl
piperazine, adding water into the obtained concentrate, adding a specific acidic
reagent to adjust the pH value of the
system to 1.0-4.5, heating to dissolve, cooling to separate out impurities, filtering, adding trichloromethane into the filtrate, extracting under the condition that the pH value is 7.0-7.5, and filtering to obtain the
levofloxacin product. And collecting an organic phase, concentrating, adding
ethanol, and crystallizing to obtain a high-purity levofloxacin product. According to the method, by limiting the
raw material ratio, the
process conditions and the specific acid
reagent, generation of an isomeride
impurity I is reduced from the reaction source, efficient separation of the
impurity I and the levofloxacin is achieved, the content of the isomeride
impurity I in the levofloxacin product is remarkably reduced, and the purity of the levofloxacin product is improved. Meanwhile, other insoluble impurities under the acidic condition are removed through
filtration, so that a high-purity product with the purity of 99.86% or above is obtained. The whole impurity removal process is simple, efficient, safe, environment-friendly and especially suitable for large-scale industrial production.