New, simple and validated kinetics spectrophotometric method for determination of moxifloxacine in its pharmaceutical formulations

Abstract

The objective of this research was to develop a kinetic spectrophotometric method for determination of moxifloxacine (MOXF) in pure form and pharmaceutical formulations. The method was based on the formation of a colored N-vinyl chlorobenzoquinone derivative of MOXF by its reaction with 2,3,5,6-tetrachloro-1,4-benzoquinone in presence of acetaldehyde.The formation of the colored product was monitored spectrophotometrically by measuring the absorbance at 652nm. Factors affecting the reaction were studied and optimized. The stoichiometry of the reaction was determined, and the reaction pathway was postulated. The activation energy of the reaction was calculated and found to be 6.65kJmol−1. Under the optimized conditions, the initial rate and fixed time (at 5min) methods were utilized for constructing the calibration graphs. The graphs were linear in concentration ranges 5–100 and 15–150 μgml−1 with limit of detection of 2.0 and 5.0μgml−1 for the initial rate and fixed time methods, respectively. The analytical performance for both methods was fully validated, and the results were satisfactory. No interference was observed from the excipients that are commonly present in the pharmaceutical formulations. The proposed method was successfully applied to the determination of MOXF in its pharmaceutical formulations. The label claim percentages were 101.25±0.73% and 100.92±0.65% for the initial rate and fixed time method, respectively. Statistical comparison of the results with those obtained by a reference spectrophotometric method showed excellent agreement between the accuracy and precision of the two methods. The proposed method has great value in its application to the analysis of MOXF in quality control laboratories.