A highly specific, sensitive, and rapid method, to quantify gemifloxacin in human urine using HPLC coupled to the triple\nquadrupole mass spectrometer system, was developed and validated. Gemifloxacin and ofloxacin (internal standard) were rapidly\nextracted from urine samples without any tedious pretreatment procedure. Urine samples were filtered through a Millex-GP,\n0.22 Ã?µm syringe filter. Optimal chromatographic separation of the analytes was achieved on Zorbax SB-C18 (30mm Ã?â?? 2mmi.d.,\n3.5 Ã?µm maintained at ambient temperature). The mobile phase consisted of 0.1% formic acid (pH 3.2) and acetonitrile (80 : 20) and\na flow rate of 0.2mLmin-1 for 4 min. The analytes were monitored by electrospray ionization in positive ion multiple reaction\nmonitoring mode. The method provided a linear response (r = 0.9998) from a quantitation range of 5 ngmL-1 to at least\n500 ngmL-1.The mean extraction recovery % of gemifloxacin from spiked human urine was 101.33 Ã?± 2.58%. The reproducibility\nof the method was reliable with the intra- and inter-day precision of <2% and accuracy within 2%. The established method was\nreliably applied for the determination of gemifloxacin in volunteersââ?¬â?¢ urine samples with the mean recoveries of gemifloxacin from\nFactive tablets 320mg > 97.0%.
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