title: Development and validation of a simple method for routine analysis of ractopamine hydrochloride in raw material and feed additives by HPLC.
abstract: A simple method was optimized and validated for determination of ractopamine hydrochloride (RAC) in raw material and feed additives by HPLC for use in quality control in veterinary industries. The best-optimized conditions were a C8 column (250 x 4.6 mm id, 5.0 microm particle size) at room temperature with acetonitrile-100 mM sodium acetate buffer (pH 5.0; 75 + 25, v/v) mobile phase at a flow rate of 1.0 mL/min and UV detection at 275 nm. With these conditions, the retention time of RAC was around 5.2 min, and standard curves were linear in the concentration range of 160-240 microg/mL (correlation coefficient > or = 0.999). Validation parameters, such as selectivity, linearity, limit of detection (ranged from 1.60 to 2.05 microg/mL), limit of quantification (ranged from 4.26 to 6.84 microg/mL), precision (relative standard deviation < or = 1.87%), accuracy (ranged from 96.97 to 100.54%), and robustness, gave results within acceptable ranges. Therefore, the developed method can be successfully applied for the routine quality control analysis of raw material and feed additives.
authors.affiliation: University of São Paulo, Department of Pharmaceutical Sciences, Faculty of Pharmaceutical Sciences of Ribeirão Preto, Ribeirão Preto, Brazil.
authors.forename: Ellen Figueiredo
authors.initials: EF
authors.lastname: Freire
authors.forename: Keyller Bastos
authors.initials: KB
authors.lastname: Borges
authors.forename: Hélio
authors.initials: H
authors.lastname: Tanimoto
authors.forename: Raquel Tassara
authors.initials: RT
authors.lastname: Nogueira
authors.forename: Lucimara Cristiane Toso
authors.initials: LC
authors.lastname: Bertolini
authors.forename: Cristiane Masetto
authors.initials: CM
authors.lastname: de Gaitani
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D005503:Food Additives / Q000032:analysis*; D010627:Phenethylamines / Q000032:analysis*
chemical_list: D005503:Food Additives; D010627:Phenethylamines; C060897:ractopamine