title: High performance liquid chromatography assay method for simultaneous quantitation of formoterol and budesonide in Symbicort Turbuhaler.
abstract: A sensitive and rapid high performance liquid chromatography method has been developed and used for the simultaneous determination of formoterol and budesonide in Symbicort Turbuhaler when assessing the aerodynamic characteristics of the emitted dose using Pharmacopoeial methods. This capability results in both time and cost saving. The mobile phase composition was acetonitrile-5 mM sodium dihydrogen orthophosphate, pH 3 (60: 40% v/v), and was passed at 1.5 ml min(-1) through a C18 column with a UV detection (wavelength 214 nm). The method was shown to give good analytical performance in terms of linearity, precision (using phenylpropanolamine as an internal standard), sensitivity and solution stability. The intra-day precision for both formoterol and budesonide were 0.75% and 1.11%, respectively (n = 10). The limit of quantitation for formoterol was 10 microgL(-1) and for budesonide was 120 microgL(-1), and the limit of detection were 3 and 30 microgL(-1), for both formoterol and budesonide, respectively. The method has been applied to determine the content of the emitted dose and the fine particle dose of Symbicort Turbuhaler.
authors.affiliation: Institute of Pharmaceutical Innovation, University of Bradford, Bradford BD7 1DP, UK. khaassi@bradford.ac.uk
authors.forename: K H
authors.initials: KH
authors.lastname: Assi
authors.forename: W
authors.initials: W
authors.lastname: Tarsin
authors.forename: H
authors.initials: H
authors.lastname: Chrystyn
mesh_terms: D000097:Acetonitriles / Q000737:chemistry; D001993:Bronchodilator Agents / Q000032:analysis / Q000737:chemistry; D019819:Budesonide / Q000032:analysis* / Q000737:chemistry; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004983:Ethanolamines / Q000032:analysis* / Q000737:chemistry; D000068759:Formoterol Fumarate; D006863:Hydrogen-Ion Concentration; D009330:Nebulizers and Vaporizers; D010665:Phenylpropanolamine / Q000737:chemistry; D010756:Phosphoric Acids / Q000737:chemistry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet
chemical_list: D000097:Acetonitriles; D001993:Bronchodilator Agents; D004983:Ethanolamines; D010756:Phosphoric Acids; D010665:Phenylpropanolamine; D019819:Budesonide; C030242:phosphoric acid; D000068759:Formoterol Fumarate; C032159:acetonitrile