Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume 45,
Number 4, April 2007, pp.220-226
Development and Validation of an Ion-Pairing RP-HPLC
Method for the Estimation of Gatifloxacin in Bulk and Formulations
Kolachina Venugopal, Movva Snehalatha, Girish
Bende, and Ranendra Saha
Birla Institute of Technology and Science, Pharmacy Group, FD
III and EDD, BITS Pilani Rajasthan 333031
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 25mM 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 ¥
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.
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