Background: Mixtures of Fluorinated Quinolones and Nitroimidazole antibacterial drugs take a significant place in the treatment of different inflammatory diseases. The necessity to develop analytical techniques for quality control is inextricably related to the introduction of new mixed dose forms into clinical practice.
Objective: The objective of our study is to develop HPLC methods for the analysis of Fluorinated Quinolones in combinations with Nitroimidazole antibiotics.
Methods: We developed and described an HPLC method for the quantitative determination of model mixtures composed of Metronidazole and Ofloxacin, Tinidazole, and Ciprofloxacin. HPLC method has been developed for the quantitative determination of Metronidazole and Ciprofloxacin in model tablets. The methods have been validated according to the requirements of European Pharmacopoeia 7.0 and the ICH criteria in terms of: selectivity, linearity, repeatability, accuracy, limit of detection, and limit of quantification.
Results: The tests are highly efficient liquid chromatographic with and without the use of highly specialized consumables (chiral chromatographic column) and are characterized by excellent reproducibility, accuracy, high sensitivity, and selectivity.
Conclusion: The methods would be useful and applicable in routine analytical practice, as well as for regulatory institutions in the control of newly registered generic products.