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Validated Method Development for Estimation of Formoterol Fumarate and Mometasone Furoate in Metered Dose Inhalation Form by High Performance Liquid Chromatography

Katari Srinivasarao, Vinayk Gorule, Venkata Reddiah Ch and Venkata Krishna A

A simple, precise, accurate, and stability-indicating method is developed and validated for analysis of formoterol fumarate and mometasone furoate in metered dose inhalation formulations. Separation was achieved on a reversed-phase C₁₈ column (150 mm×4.6 mm i.d., 5 μm) using a mobile phase consisting of Sodium dihydrogen orthophosphate buffer/acetonitrile (50:50, v/v) at a flow rate of 1.0 mL/min and UV detection at 220 nm. This method is validated according to united States Pharmacopia requirements for new methods, which include accuracy, precision, selectivity, robustness, and linearity and range. This method shows enough selectivity, accuracy, precision, and linearity and range to satisfy Federal Drugs Administration/International Conference on Harmonization regulatory requirements. The current method demonstrates good linearity over the range 0.01-0.20 mg/mL of formoterol fumarate with r²=0.999 and 0.40-6.00 mg/mL of mometasone furoate with r²=0.999. The average recovery of the method is 99.9% of formoterol fumarate with a relative standard deviation of 1.94% and 101.5% of mometasone furoate with a relative standard deviation of 0.81%. The degree of reproducibility of the results obtained as a result of small deliberate variations in the method parameters and by changing analytical operators has proven that the method is robust and rugged.