Development and validation of an ion-pairing RP-HPLC method for the estimation of gatifloxacin in bulk and formulations.

A new, simple, and sensitive ion-pair reverse-phase liquid chromatographic method is developed and validated for the estimation of 1-cyclopropyl-6-fluoro-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxo-1,4-dihydro-quinoline-3-carboxylic acid (gatifloxacin) in bulk and formulations using a UV detector under isocratic conditions. The selected mobile phase consists of the aqueous phase (a 25 mM citrate buffer comprising of 10mM cationic and anionic pairing agents, pH adjusted to 3.5) and acetonitrile (52:48%, v/v). The selected wavelength is 292 nm. Retention time of gatifloxacin is 5.2 min. The linearity range is found to be 50 to 1000 ng/mL (the regression equation is area = 105.5 x concentration in ng/mL--695.8), and the regression coefficient is 0.9996. Validation results demonstrate accuracy, precision, and reproducibility (relative standard deviation < 3%) of the method. The detection and quantitation limits are found to be 6.50 and 17.38 ng/mL, respectively. The method is successfully used for the estimation of gatifloxacin in a variety of dosage forms, and the results are in good agreement with the label claims.