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

Abstract

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. In the impurity method new developed, Inertsil ODS-3 HPLC column, buffer solution with a pH of 3 and acetonitrile mobile phase mixture in isocratic elution were used. Mobile phase flow rate was 1.0 ml/min and detector wavelength were adjusted to be 330 nm. In the quantity determination method, Inertstil C8 HPLC column, a buffer solution having a pH of 3, methanol and acetonitrile mobile phase mixture in gradient elution was employed. In this method also, mobile phase flow rate was preferred to be 1.5 ml/min and detector wavelength as 330 nm.