Simultaneous Estimation of Fluticasone propionate, Azelastine Hydrochloride, Phenylethyl alcohol and Benzalkonium chloride by RP-HPLC Method in Nasal spray preparations

Abstract

A simple, reproducible and accurate efficient reverse phase high performance liquid chromatographic method was developed for simultaneous estimation of Fluticasone propionate (FLP), Azelastine Hydrochloride (AZH), Phenylethyl alcohol (PEA) and Benzalkonium chloride (BKC) in combined nasal spray preparations. Formulation containing FLP with AZH are used as antihistamine-corticosteroid combination available as a metered spray formulation for nasal or intranasal administration. Chromatography was performed on a 250 mm ✖ 4.6 mm, 5-μm particle size, Waters Spherisorb CN column with a 55:45 (v/v) mixture of buffer and acetonitrile as a mobile phase. The detection of the combined dosage form was carried out at 215 nm and flow rate employed was 1.0 ml/min. The retention times were 3.380, 4.855, 6.647 & 10.175, 12.179 min for Phenylethyl alcohol, Fluticasone propionate, Azelastine Hydrochloride and Benzalkonium chloride (C12, C14), respectively. Linearity was established in the concentration range 70.0 to 120.0 μg/ml for Phenyl ethyl alcohol, 14.0 to 24.0 μg/ml for Fluticasone propionate, 39.2 to 67.2 μg/ml for Azelastine Hydrochloride and in the range 2.8 to 4.8 μg/ml for Benzalkonium chloride, with a correlation coefficient of 0.9961, 0.9992, 0.997 and 0.9997, respectively. The results of the analysis were validated statistically and recovery studies confirmed the accuracy and precision of the proposed method.