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.
Cite this article:
Sri Datla VVSSN. Raju, A. Manikandan. Reverse Phase High Performance Liquid Chromatographic Method for the Simultaneous Determination of Clarithromycin, Tinidazole and Rabeprazole in combined Formulations. Research J. Pharm. and Tech 2021; 14(3):1333-1338. doi: 10.5958/0974-360X.2021.00237.7
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