A New Stability Indicating Validated RP-HPLC Method for the Simultaneous Estimation of Azithromycin and Cefixime in Bulk and Pharmaceutical Dosage Forms

A simple, rapid, specific, accurate and precise stability indicating reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Azithromycin and Cefixime in Bulk and Tabletdosage form. An Agilant Zorbax C8, 5 μ column having 150 x 4.6mm id in Isocratic mode with mobile phase containing 0.1M Dipotassium Hydrogen Phosphate Buffer: methanol (60:40%v/v pH: 8.0 adjusted with Ortho phosphoric acid) was used. The flow rate was 1ml/min and effluents were monitored at 230nm. The retention time of Azithromycin and Cefixime was 2.7min and 4.6min respectively. The concentration curves were linear in the concentration range of 250–750μg/mL and 200–600 μg/mL. The drug was subjected to acid and alkali hydrolysis, oxidation, photolysis and heat as stress conditions. The developed method was validated for specificity, precision, linearity, accuracy, LOD,LOQ, robustness. Recovery of Azithromycin and Cefixime in formulations was found to be in the range of 98% -102% and 98%-102% respectively confirms the non-interferences of the excipients in the formulation. Due to its simplicity, rapidness and good precision, the proposed HPLC method may be used for the simultaneous determination of these two drugs in pharmaceutical dosage forms.