A New Validated Method for Simultaneous Determination of Aerodynamic Particle Size Distribution of Drug Particles of Mometasone Furoate and Formoterol Fumarate Dihydrate in 200 mcg/5 mcg Inhalation Aerosol

Simultaneous determination of aerodynamic particle size distribution (APSD) of drug particles of mometasone furoate and formoterol fumarate dihydrate – 200 mcg/5 mcg inhalation aerosol (MDI) has been developed and reported in this work. The method was developed in consistent with USP <601> inhalation and nasal drug products e.g. aerosols, sprays and powders. The next generation impactor (NGI) was used and operated at 30 ± 5% L/min. The proposed method was demonstrated for sensitivity, minimum number of actuations, diluent volume optimization, mass balance and precision. The proposed method was found to be robust, accurate, linear and precise.

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