Stability indicating reversed phase-HPLC method for simultaneous estimation of mometasone furoate
(MAF) and formoterol fumarate (FFD) in metered dose inhalation aerosol (MDI) dosage formulation
has been developed and discussed in the present work. The chromatographic separation was achieved
using Hypersil ODS column (250 mm × 4.6 mm, 3 μm) using an isocratic separation mode at a flow
rate of 1.2 mL/min, column temperature of 50 ºC. The system operates with a mobile phase comprising
of solution-A (buffer): Solution-B (acetonitrile) mixed in the ratio of 70:30 %v/v at a UV detection
wavelength of 214 nm. Retention times of mometasone furoate and formoterol fumarate found to be
about 3 min and 7 min, respectively. All possible degradation products of both compounds were
monitored at 214 nm and spectral purity along with % mass balance is assessed using PDA detector.
Both analyte were subjected to force degradation studies, found all degradants were resolved from
analyte peaks and also other process-related impurities. The proposed method is validated for specificity,
linearity, accuracy, precision and robustness as per ICH guidelines and found to be adequate. Method
stood to be robust with variation in column temperature, flow rate, pH of buffer and organic content in
mobile phase.