High performance liquid chromatography determination of prulifloxacin and five related impurities in pharmaceutical formulations

Abstract

A novel HPLC method for the simultaneous determination of Prulifloxacin, Ulifloxacin, its process impurities in a tablets formulation and Enrofloxacin, used as Internal Standard, is developed. The separation was successfully carried out with a new stationary phase, HILIC, under isocratic elution mode using ammonium acetate buffer (5mM, pH 5.8) and acetonitrile (12:88, v/v) at a flow rate of 1.0mL/min. Column was thermostated at 25°C (±1°C) and 20μL were injected for the analysis.Calibration curves were linear in the investigated range with correlation coefficient better than 0.9880, while the limit of quantifications ranged from 0.25 to 5μg/mL, depending from the analyte.The within and between batch precision (RSD%) values ranged from 0.11% to 13.9% while within and between batch trueness (bias%) values ranged from 14.0% to −11.3%.This method for the direct determination and quantification of process impurities in pharmaceutical formulations is suitable for routine analyses in quality control laboratories and was applied to evaluate for the first time, the presence and the quantities of cited analytes in commercially available formulation.