Archive \ Volume.5 2014 Issue 2

STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF MOMETASONE FUROATE AND FORMOTEROL FUMARATE IN COMBINED DOSAGE FORM

Pooja Z Gujarati , Krupa C Thula and Dilip G Maheshwari
Abstract

A simple, specific, accurate, and stability indicating reversed-phase high-performance liquid chromatographic method was developed for the simultaneous determination of formoterol fumarate and mometasone furoate using a Enamal C18 column and a mobile phase composed of acetonitrile: 0.05 M orthophosphoric acid: methanol (60:30:10 v/v), pH 3. The retention times of formoterol fumarate and mometasone furoate found to be 1.68 min and 7.17 min, respectively. Linearity was established for of formoterol fumarate and mometasone furoate in the range of 3-9 μg/ ml and 100-300 μg/ml, respectively. The percentage recoveries of formoterol fumarate and mometasone furoate were found to be in the range of 98.66-99.31%. Both the drugs were subjected to acid and base hydrolysis, oxidation, photolytic, and thermal degradation conditions. The degradation products of formoterol fumarate and mometasone furoate were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for simultaneous quantitative analysis of formoterol fumarate and mometasone furoate in bulk drugs and formulations.


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