DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF LEVOFLOXACIN IN TABLET USING UV AND FLUORESCENCE DETECTORS SIMELTANIOUSLYAbstract
Simple, sensitive, precise, accurate, and specific reversed –phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of levofloxacinin pharmaceutical tablets. Levofloxacin is a third generation fluoroquinolones with a wide spectrum of action against gram-positive and gram-negative bacteria, anaerobic microorganisms and atypical pathogens. It is pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin, which was introduced in 1997. Isocratic chromatography was performed on a C18 column with acetonitrile‐methanol‐phosphate buffer 0.1M15:25:60 (v/v/v) as mobile phase at a flow rate of 1 ml/min. UV detection was set at 287 nm. The fluorescence detector was set at excitation/emission wavelengths of 300/500 nm. The method was validated with respect to accuracy, linearity, precision, and selectivity. All the parameters examined met the current recommendations of U.S.P (30) for analytical method validation. The method can be reliably used for routine quality control analysis and to determine the levofloxacin content of marketed tablets.