Authors : R. T. Badwaik, A. V. Dashputra, M. M Gupta
Volume : 3
Issue : 3
Year : 2012
Page No : 14-19
Objectives: Levofloxacin is pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin, which was introduced in 1997. It is a third generation fluoroquinolones with a wide spectrum of action against gram-positive and gram-negative bacteria, anaerobic microorganisms and atypical pathogens. Various analytical methods have been reported in scientific literature for the analysis of levofloxacin in pharmaceutical formulations. The price of different oral formulations of levofloxacin varies considerably. Generic tablets are cheaper than branded ones. In order to assure the bioequivalence and therapeutic equivalence, pharmaceutical equivalence study needs to be investigated and hence the present study was undertaken to compare the pharmaceutical equivalence of the generic and some branded oral formulations of levofloxacin and to compare the findings of spectrophotometer and high performance liquid chromatography (HPLC). Methods: Levofloxacin was estimated by using UV spectrophotometer. Linearity curve was obtained in the concentration range of 2-12µg/ml at 293.7 nm using pure levofloxacin and 0.1 N HCl as a solvent system. The concentration in various formulations was obtained by using calibration curve. The quantitative measurements were also obtained by HPLC at 293 nm by using mobile phase consisting of 0.05M phosphate buffer: acetonitrile (80:20, v/v) with 0.2% of triethylamine and pH adjusted to 3 with phosphoric acid. Results: All formulations were found to be pharmaceutically equivalent. The spectrophotometric method was comparable to HPLC. Conclusion: Being simple, rapid, reliable and cost-effective spectrophotometer method can be applied for routine analysis of levofloxacin and for pharmacokinetic study.