ABSTRACT
OBJECTIVE:To prepare pazufloxacin mesilate ophthalmic gel and to establish its quality control method.METHODS:The gel was prepared with pazufloxacin mesilate ophthalmic as principal agent and with PVA-124 as base material.The content of pazufloxacin mesilate was determined by HPLC and the stability of the gel was investigated as well.RESULTS:The prepared gel was yellowish liquid and its property fitted the description of Chinese Pharmacopeia(2005 edition).The linear range of pazufloxacin mesilate was 20.0～80.0 ?g?mL-1(r=0.999 9),and the average recovery was 98.67%(RSD=0.79%,n=3).No stratification was noted for the sample within 2-month storage under room temperature.CONCLUSION:The preparation technique of the pazufloxacin mesilate ophthalmic gel is simple and feasible,its quality control method is rapid and the determination result is accurate and reliable.
ABSTRACT
OBJECTIVE:To establish a RP-HPLC analytical method for the determination of pazufloxacin mesilate in human plasma and urine.METHODS:The plasma proteins were precipitated with methanol and the supernatant liquid ob-tained from the serum centrifugate was subjected to chromatographic analysis.The supernatant liquid obtained from the diluted urine centrifugate was subjected to sample introduction.The analytical column was Diamonsil C 18 ,the mobile phase consisted of acetonitrile-0.05mol/L potassium dihydrogen phosphate(containing1%tetrabutylammonium bromide)(8∶92,V/V)with a flow rate at1.4ml/min,excitation wavelength at320nm and emission wavelength at400nm.RESULTS:The linear range of pazufloxacin mesilate in both plasma and urine was31.25～10000ng/ml(r=0.9999).The relative recoveries of pazu-floxacin mesilate in human plasma and urine were97.77%～99.87%and98.31%～100.82%,respectively with RSD less than1.0%～3.0%.CONCLUSION:This method is accurate,reliable and simple and it is suitable for the pharmacokinetic study and routine monitoring of blood concentration of pazufloxacin mesilate.