Development and validation of a simple method for routine analysis of ractopamine hydrochloride in raw material and feed additives by HPLC.
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.
Freire
Ellen Figueiredo
EF
University of São Paulo, Department of Pharmaceutical Sciences, Faculty of Pharmaceutical Sciences of Ribeirão Preto, Ribeirão Preto, Brazil.
Borges
Keyller Bastos
KB
Tanimoto
Hélio
H
Nogueira
Raquel Tassara
RT
Bertolini
Lucimara Cristiane Toso
LC
de Gaitani
Cristiane Masetto
CM
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D005503:Food Additives / Q000032:analysis*; D010627:Phenethylamines / Q000032:analysis*
D005503:Food Additives; D010627:Phenethylamines; C060897:ractopamine