A Rapid, Stability-Indicating RP-UPLC Method for the Simultaneous Determination of Fluticasone Furoate and Benzalkonium Chloride in a Pulmonary Drug Product

Abstract

A stability-indicating reversed-phase ultra performance liquid chromatography (RP-UPLC) method was developed for the simultaneous determination of fluticasone furoate (FF) and benzalkonium chloride (BKC) in a pulmonary drug product. The desired chromatographic separation was achieved on the BEH C18, 1.7 µm (50 x2.1 mm) column, using isocratic elution at 215 nm detector wavelength. The optimized mobile phase consisted of 0.05 M potassium dihydrogen phosphate buffer and acetonitrile in the ratio of 45:55% v/v. The developed method separated FF and BKC within 5 minutes. The stability-indicating capability was established by forced degradation experiments. The developed RP-UPLC method was validated according to the International Conference on Harmonization (ICH) guidelines. This validated method was applied for the simultaneous estimation of FF and BKC in commercially available Furamist ® (Nasal spray formulation) sample. Furthermore, this method can be extended for individual estimation of FF and BKC in various commercially available pulmonary drug products.