DEVELOPMENT AND VALIDATION OF HPLC-METHOD DETERMINING QUANTITATIVE CONTENT OF CEFTIOFUR HYDROCHLORIDE IN SUSPENSIONS FOR INJECTION

Ceftiofur is a third-generation cephalosporin used in veterinary medicine to treat infections caused by gram-negative and gram-positive bacteria. It most often the form of suspensions for injections based on lipid matrix, since active substance poorly soluble water. The analysis such drug direct spectrophotometry difficult due components therefore it proposed develop high-performance liquid chromatography method with UV detection.
 aim work was identification quantitative determination ceftiofur hydrochloride injections. developed validated according indicators selectivity, robustness, linearity suitability parameters chromatographic system. Suspension containing 50 mg/ml as sample-object development. standard sample test were dissolved mobile phase concentration μg/ml. total uncertainty 1.62%, which within limits recommended DFU 2.0. samples separated Dionex Ultimate 3000 chromatograph equipped Kinetex C18-XB 150×4.6, 5 μm column. mixture acetonitrile 0.05 M ammonium acetate, 0.01 tetrabutylammonium bromide pH 6.8, titrated acetic acid, volume ratio 3:7. detected spectrophotometrically at wavelength 290 nm.
 Under above conditions, possible completely separate (retention time peak – 4.4 min) other studied drug. At same time, system did not exceed specified recommendations USA Food Drug Association. For peak, efficiency 13,900 theoretical plates. relative deviation (RSD) areas ±0.11 %, separation coefficient (RS) from 17.3. symmetry 1.02. calibration curves linear 2.0 range (80–120% nominal corresponding substance). (R2) area 0.9992.