Locatelli, Marcello published the artcileHigh performance liquid chromatography determination of prulifloxacin and five related impurities in pharmaceutical formulations, Synthetic Route of 113028-17-4, the main research area is prulifloxacin impurity determination HPLC tablet.
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 (5 mM, pH 5.8) and acetonitrile (12:88, volume/volume) at a flow rate of 1.0 mL/min. Column was thermostated at 25 °C (±1 °C) and 20 μL were injected for the anal. 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 5 μg/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 1st time, the presence and the quantities of cited analytes in com. available formulation.
Journal of Pharmaceutical and Biomedical Analysis published new progress about HPLC. 113028-17-4 belongs to class piperazines, name is Ethyl 6-fluoro-1-methyl-4-oxo-7-(piperazin-1-yl)-1,4-dihydro-[1,3]thiazeto[3,2-a]quinoline-3-carboxylate, and the molecular formula is C18H20FN3O3S, Synthetic Route of 113028-17-4.
Referemce:
Piperazine – Wikipedia,
Piperazines – an overview | ScienceDirect Topics