Investigation of chromatographic conditions for the separation of ofloxacin and its degradation products

Abstract

A sensitive, precise, and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for simultaneous determination of fluoroquinolone antibacterial ofloxacin and its degradation products: decarboxy ofloxacin, 9-piperazino ofloxacin, des-methyl ofloxacin, and ofloxacin-N-oxide. The proposed RP-HPLC method allowed separation of all five compounds simultaneously with the total time of the analysis not more than 15 min. The relative standard deviation (RSD) values for quantification of DOF, POF, MOF, OF, and NOF were of 0.77, 0.58, 0.51, 0.10, and 0.70%, respectively, indicating a good precision of the method. The limits of detection for DOF, POF, MOF, OF, and NOF were 0.10, 0.13, 0.06, 0.03, and 0.03 mu g mL(-1), respectively. The described method can be used for simultaneous identification and quantification of all analysed compounds in different pharmaceutical formulations.