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.