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

Abstract

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.