A new stability indicating RP-UFLC method for the quantification of Gemifloxacin tablets using an ion pairing agent

Gemifloxacin is a new broad-spectrum quinolone antibacterial with activity against both Gram-negative and Gram-positive organisms. A new stability indicating RP-UFLC method was proposed for the estimation of Gemifloxacin in pharmaceutical dosage forms (tablets). Shimadzu Model CBM-20A/20 Alite UFLC system with PDA detector and Zorbox C¹⁸ column were used for the chromatographic study. Mobile phase mixture consisting of Tetra butyl ammonium hydrogen sulphate and Acetonitrile in the ratio 68: 32, v/v with a flow rate 0.8 mL/min was chosen for the chromatographic elution of Gemifloxacin (Detection wavelength 273 nm). The method was linear over the concentration range 0.02-200 mg/ml with linear regression equation, y = 207068x + 19935 (R²; = 0.9999). The LOD and LOQ were found to be 0.0553 mg/ml and 0.1693 respectively. Forced degradation studies were performed and the method was validated as per ICH guidelines.