Reverse phase high performance liquid chromatographic method for the simultaneous determination of clarithromycin, tinidazole and rabeprazole in combined formulations

A simple reproducible stability indicating RP-HPLC method was developed for the simultaneous determination of clarithromycin, tinidazole and rabeprazole in their combined dosage forms, and for drug dissolution studies. A using Phenomenex C18, 5μm, 250mm x4.6 mm i.d. columnand a mobile phase of Phosphate buffer (30mM) pH-4.5, Acetonitrile and Methanol in the ratio of 30: 50: 20%v/v mixture were used for separation and quantification of clarithromycin, tinidazole and rabeprazole. The present drug analytes were run at a flowrate of 1.0ml/min at ambient temperature. The injection volume was 10μL and with ultraviolet detection at 260nm. Under these conditions, cclarithromycin, tinidazole and rabeprazole were eluted at 3.393min, 4.576minand 6.319min, respectively with a total run time shorter than 10min. The developed method was validated according International Conference on Harmonization (ICH) guidelines. The developed RP-HPLC method was applied successfully for quality control assay of clarithromycin, tinidazole and rabeprazole in their combination drug product and in vitro dissolution studies.