Developing and validation of impurity and the simultaneous quantity determination methods for tablet forms containing Ciprofloxacin HCl and Ornidazole.

In this study simple, effective, fast and economic reverse-phase HPLC methods have been developed for the purposes of identifying impurities and quantities of the two active ingredients in the tablet dosage products containing Ciprofloxacin HCl and Ornidazole together. These methods have been validated according to the parameters of International Conference on Harmonization (ICH) and Centre for Drug Evaluation and Research (CDER) to prove reliability and applicability of the methods. In the validation studies, all of the parameters defined in ICH as selectivity, precision, accuracy, linearity, LOD, LOQ, recovery, robustness and solution stability were tested.