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.
Highlights
Allergic rhinitis is a common disease and refers to inflammation of the nasal passages including sneezing, itching, nasal congestion and runny nose
We developed a reversed-phase high-performance liquid chromatography (RP-High performance liquid chromatography (HPLC)) method for determination of phenylethyl alcohol in Budesonide nasal spray and similar formulations which this analysis method is simple, fast, short response time, cheap price, with high accuracy and high precision
HPLC grade acetonitrile was procured from Merck Company (Germany), pure standard of phenylethyl alcohol (99.9 % w/w) was obtained from LGC Company (England) and HPLC grade water was prepared by using Millipore Milli Q plus purification system (USA)
Summary
Allergic rhinitis is a common disease and refers to inflammation of the nasal passages including sneezing, itching, nasal congestion and runny nose. Intranasal corticosteroids are among the most effective treatments for permanent allergic rhinitis. Some individuals unable to tolerate aerosols may prefer an aqueous nasal spray (Mygind, 1993). Budesonide, the active component of budesonide nasal spray is a corticosteroid designated chemically as (RS)11β, 16α, 17, 21-Tetrahydroxypregna-1, 4-diene-3, 20-.
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