DETERMINATION OF LEVOFLOXACIN IN PHARMACEUTICALS AND HUMAN URINE BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

Abstract

   A reversed-phase HPLC method was developed and validated for quantification oflevofloxacin (LEV) in pharmaceuticals and human urine sample. The optimal HPLCconditionswere as follows: C18 MRC-ODS (6 × 250 mm, 15 μm) column, mobilephase of acetonitrile: 20 mM phosphate buffer, pH=3 (30:70 v/v), flow rate at 0,8ml/min, and detection wavelength of 295 nm at room temperature. LEV inpharmaceutical samples was extracted with acetonitrile in an ultrasonic bath for 15min. The liquid - liquid and solid-phase extraction procedures for LEV in humanurine samples were proposed. Dichloromethane was used for liquid - liquidextraction. Hydrophilic-lipophilic balance Oasis HLB cartridge was used for solidphase extraction. The recoveries of LEV determined by liquid-liquid and solid phaseextraction method were 87 and 94 %, respectively. The detection limit of LEV was0.03 ppm with a RSD < 1.3 % (n=3). The results of LEV analyses in pharmaceuticalsamples were consistent with those labelled in commercial formulations. LEVconcentrations in urine samples of patients inoculated with dose of 750 mg/150 mlafter 4-10 h ranged from 30 - 65 ppm.