SIMULTANEOUS HPLC METHOD DEVELOPMENT FOR AZELASTINE HCl AND FLUTICASONE PROPIONATE NASAL SPRAY FORMULATION

Abstract

Azelastine HCl and fluticasone propionate nasal spray drug product is commonly used to treat moderate to severe allergic rhinitis and rhino-conjunctivitis. To date, a simultaneous HPLC method for active substances and impurities of these products has not been reported. Acetonitrile and buffer (octane-1-sulfonic acid sodium salt and potassium dihydrogen phosphate) were used as a mobile phase. Separation was achieved using Phenomenex Phenyl-hexyl (150 cm × 4.6 mm, 5 μm) column at 1 mL/min flow rate in gradient elution mode. The chromatograms were monitored at 240 nm. Validation parameters such as linearity, limit of quantification, limit of detection, accuracy, precision, robustness, and specificity were investigated for the nasal spray. Overall, this study provides valuable insights into the development and validation of an efficient analytical method for assessing the quality and stability of a combination of azelastine HCl and fluticasone propionate nasal spray.