VALIDATED METHOD DEVELOPMENT FOR ESTIMATION OF FORMOTEROL FUMARATE AND MOMETASONE FUROATE IN METERED DOSE INHALATION FORM BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

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 X 4.6 mm i.d., 5μm) 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 Pharmacopeia 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 r 2 0.999 and 0.40-6.00 mg/mL of mometasone furoate with r 2 0.999. The average recovery of the method is 99.9 % o