Development and Validation of an HPLC Method for Analysis of Gemifloxacin in Human Plasma

A simple high-performance liquid chromatographic method for the determination of Gemifloxacin in human plasma has been developed. Separation was achieved by Reverse phase chromatography on a Purospher RP18e (150×4.6 mm, 5 μm) column with mobile phase composition of pH 3.0 buffer: acetonitrile: Methanol in the ratio 75:17:8 v/v with ultra violet detection at 273 nm. Lower limit of quantitation was 50 ng/ml. Maximum between-run precision was 7.44%. Mean extraction recovery was found to be 92.53 to 109.87%. Stability study showed that after three freeze-thaw cycles the loss of three quality control samples were less than 10%. Samples were stable at room temperature for 48 h and at -20° for 2 months. Before injecting onto HPLC system, the processed samples were stable for at least 6 h. The method was used to perform bioequivalence study in human.