LAUSR

The place occupied by fluoroquinolones is very important clinically. Ciprofloxacin has been the most widely prescribed one which exhibits good activity against Pseudomonas aeruginosa and Acinetobacter. D-glucose is frequently used as an excipient in most formulations for perfusion solutions. Since there is much interest in pharmaceutical quality control of such formulations, separation of impurities from the main drug substances and accurate assay quantification, and since there is no reference or monograph until nowadays that has been reported for the simultaneous separation of ciprofloxacin degradation products along with 5-hydroxymethyl-furfural (5-HMF), impurity of D-glucose, classified as a high toxic substance, thus our aim of this work is to develop a new simple, sensitive and stability indicating method allowing this separation by high-performance liquid chromatography. We have started from the chromatographic conditions recommended by the British Pharmacopoeia, and by optimizing the nature of the stationary phase, the composition of the mobile phase and the injection volume. After optimisation, the retained chromatographic conditions have enabled the separation of all impurities with good resolution factor greater than 1.5 for each pair of peaks and with good symmetry peak shape. The developed method was validated according to the International Conference of Harmonisation (ICH) guidelines for specificity, detection and quantification limits, and then it was applied to stability study of the formulation subjected to different ICH prescribed stress conditions. The 5-HMF was checked to be the impurity issued from D-glucose hydrolysis by high temperature mainly after autoclaving of pharmaceuticals. The developed method was proved to be simple, specific with very low limit of quantification. Hence, it can be considered as a method for stability indicating and routine quality control analysis in pharmaceutical industries.