USP 38 monograph - impurities test for levofloxacin using a C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the analysis of levofloxacin and its impurities. The separation was performed on a Thermo Scientific Acclaim 120 C18 HPLC column using the method described in the USP 38 monograph. The results obtained for % relative standard deviation and signal to noise ratio exceeded the criteria stated in the USP. Relative standard deviation for system suitability solution was 0.1% (USP criteria of not more than 1.0%) and signal to noise ratio for sensitivity solution was 58 (USP criteria not less than 10).