Chiral separation and purity test of levofloxacin-N-oxide / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish a high performance liquid chromatographic method for chiral separation of levofloxacin-N-oxide enantiomers and purity test of the bulk drug. METHODS: The analysis was carried out on a C18 column with D-phenylalanine-copper sulfate solution-methanol (80:20) as mobile phase. The flow rate was 1.0 mL · min-1, the UV detection wavelength was set at 325 nm, and the column temperature was maintained at 40℃. RESULTS: A baseline separation of levofloxacin-N-oxide enantiomers was achieved and the resolution was 3.2 between the enantiomers under the above chromatographic conditions. CONCLUSION: This method is simple, rapid, and reproducible, and it can be used for the separation and purity test of levofloxacin-N-oxide.