Development and Validation of Assay Method for the Estimation of Moxifloxacin in Bulk and Pharmaceutical Formulations by RP-HPLC.

A simple, specific, and isocratic reversed phase-high performance liquid chromatography (RP-HPLC) method with UV detection at 293 nm and column Agela Technology, Venosil XBP C18, (Venosil XBP, 4.6mm×250mm, 10µm) was developed and validated for analysis of moxifloxacin hydrochloride (MOXI) in presence of its degradation products. The retention time of the MOXI was found at 9.99 min. A mobile phase consisting of phosphate buffer and methanol (18:7 v/v) at flow rate of 1.3mL/min, at temperature 50°C maintained by using column oven in the study. While 0.1N HCl was used as diluent. The calibration curves were linear with correlation coefficient (R2) of 0.999. The detection and quantification limit were found as 0.029 µg mL-1 and 0.095 µg mL-1 respectively. The method was validated in accordance with International Conference on Harmonization (ICH) guidelines. The proposed method was found sensitive, specific and was successfully applied for the estimation of MOXI in pharmaceutical formulations. Innumerable analytical measurements are made for the estimation of MOXI in pharmaceutical formulations, so the proposed analytical method leads to provision of cost effective by using low-cost diluents and the reagents.