Analytical Method Development and Validation for HPLC-ECD Determination of Moxifloxacin in Marketed Formulations

摘要

An HPLC-ECD analytical method with high reproducibility and wide linearity range has been developed and validated. Moxifloxacin was separated and identified using this method with a simple mobile phase comprising Britton Robinson buffer pH 5.0 and methanol (93: 7 v/v) flowing at a rate of 0.5 mL/min through Acclaim C-18 column (150 mm x 4.6 mm x 5 im) maintained at 35 degrees C and detected at redox potential value of 1.0 V. The LOD and LOQ were found to be 2.2 and 6.6 g/mL, respectively. The HPLC-ECD method of moxifloxacin analysis was validated as per ICH Q(2)R(1) guidelines and applied for assay of marketed moxifloxacin formulations to establish the acceptable recovery.