Determination of phenylethyl alcohol by reversed-phase high-performance liquid chromatography (RP-HPLC) in Budesonide nasal spray

Abstract

Phenylethyl alcohol is used as an antimicrobial preservative in many pharmaceutical products, especially nasal sprays. A simple and accurate reverse phase high performance liquid chromatographic method was developed to assay of phenylethyl alcohol in budesonide nasal spray preparations. A waters C18 symmetry column chromatographic system (150 × 4.6 mm, 5 µm particle size) was performed with a 50:50 (%V/V) mixture of water and acetonitrile as a mobile phase. The detection of the phenylethyl alcohol was carried out at 220 nm and flow rate was employed 1.0 ml/min. The retention time of phenylethyl alcohol was about 2.8 min. Linearity was established in the concentration range of 173.28 to 259.92 mg/ml (80 to 120% of the target concentration), with a regression coefficient of 0.9991. Specificity was tested in the presence of placebo; no interference was detected at the retention time of phenylethyl alcohol. The results of the analysis were validated statistically and recovery percentage studies confirmed the accuracy and precision of the proposed method.   Key words: Phenylethyl alcohol, budesonide, nasal spray, reversed-phase high-performance liquid chromatography (RP-HPLC), preservative.