Novel synthesis of gatifloxacin

Abstract

Provided are a method for making (±)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolenecarboxylic acid, commonly known as gatifloxacin, in high purity, in a suspension in a dipolar aprotic solvent.

1 . Gatifloxacin containing about 0.07% or less desmethyl gatifloxacin and about 0.06% or less 2′-methyl gatifloxacin.  
     
     
         2 . Gatifloxacin containing about 0.1 area-% or less 2′-methyl gatifloxacin.  
     
     
         3 . The gatifloxacin of  claim 2  having about 0.06 area-% or less 2′-methyl gatifloxacin.  
     
     
         4 . Gatifloxacin containing not more than about 0.1 total area-% of impurities.  
     
     
         5 . A pharmaceutical composition comprising gatifloxacin that contains about 0.07% or less desmethyl gatifloxacin and about 0.06% or less 2′-methyl gatifloxacin.