A simple and rapid high performance liquid chromatography method to determine levofloxacin in human plasma and its use in a bioequivalence study.

A simple and rapid HPLC-UV method has been developed for determination of levofloxacin in human plasma. Chromatographic separation was performed on a Kromasil C18 column with the mobile phase consisting of acetonitrile, water, phosphoric acid and triethylamine (14:86:0.6:0.3, v/v/v/v) and flow rate was 1.0 mL/min. The method used ultraviolet detection set at a wavelength of 294 nm. The standard curves were linear over concentration range of 0.05-5.0 μg/mL (r > 0.99). The method was simple, rapid, precise, accurate and suitable for routine bioequivalence study. The method was successfully applied to the bioequivalence study of two different levofloxacin hydrochloride capsules in Chinese healthy volunteers.