Stability-Indicating HPLC Method for the Determination of Mometasone Furoate, Oxymetazoline, Phenyl Ethanol and Benzalkonium Chloride in Nasal Spray Solution

Abstract

A sensitive stability-indicating reversed-phase high performance liquid chromatographic method was developed for the simultaneous determination of mometasone furoate (MON), oxymetazoline (OXY), phenyl ethanol (PEL) and benzalkonium chloride analogs (BKC1and BKC2) in nasal spray solution. The chromatographic separation was achieved on Cosmosil CN 150 mm x 4.6mm, 5 um column Using a mobile phase consisting of 50 mM KH2PO4 and Acetonitrile in the ratio of 60:40 (v/v), at a flow rate of 2.0 ml/min. The column compartment temperature was set at 40°C. The typical HPLC chromatograms were extracted at 215 nm using a photodiode-array detector (PDA). The inter-day and intra-day precision values are found within 2% of relative standard deviation. The described method gives LOQ values of 21 ng/mL for MON, 23 ng/mL for OXY, 25 ng/mL for PEL, 10 ng/mL for BKC1 and 9 ng/mL for BKC2. The method shows accuracy of 99.6% for MON, 99.8% for OXY, 99.8% for PEL, 99.0% for BKC1 and 99.5% for BKC2. The described method shows excellent linearity over a range of LOQ to 150% of test concentration. The correlation coefficient for MON, OXY, PEL, BKC1 and BKC2 was 0.9998, 0.9999, 0.9998, 0.9999 and 0.9996 respectively.