A sensitive, accurate, rapid, fully validated, reliable and easy method was developed for the quantification of gemifloxacin mesylate (GEM) using liquid chromatography (LC) with DAD detection. In this method; a reversed-phase RP-18 (X-Select. 250 x 4.6 mm ID x 5u) column with a mobile phase of methanol-water (50:50;v/v) containing 15 mM phosphoric acid (pH 2.50) at 1.0 ml/min flow rate was used to separate GEM and internal standard (IS) with a detection of 272 nm. Granisetron was chosen as IS. Using these conditions, the retention times were obtained as 3.20 min for IS, 4.25 mill for GEM. All necessary validation parameters and system suitability test results were obtained in detail Linearity was obtained in the concentration range between 0.25 and 20 ug/mL. The LOD and LOQ values are 0.004, 0.013 ug/mL, respectively, Also the interday and intraday precision of the method was found as 0.069 % and 0.101 % RSD values, respectively. Also the validated method applied for pharmaceutical formulations and the accuracy were found 99.96 %, The above findings showed the proposed method is simple and has advantage of allowing for fast analysis.

Keywords: Gemifloksasin, SK, Farmasötik dozaj sekli, Miktar tayini, Validasyon