Determination of Enantiomers in Garenoxacin Mesylate by HPLC

OBJECTIVE To establish an HPLC method for determining of enantiomers in garenoxacin mesylate. METHODS The column was Chiralpak AD-H (250 mm×4.6 mm, 5 μm) was used. Column temperature was 35 ℃, detection wavelength was 278 nm, flow rate was 1.0 mL·min^-1, and the mobile phase consisted of n-hexane-isopropanol-methanol-methanesulfonic acid(70∶29∶1∶0.1). RESULTS The calibration curves of garenoxacin and enantiomers were linear over the range of 0.005-0.151 μg·mL^-1(r>0.999). The limit of quantification was 5 ng·mL^-1(equivalent to 0.03%). The minimum detection limit was 2.5 ng·mL^-1(equivalent to 0.015%). CONCLUTION The method is sample, accurate, reproducible and specific for determination of ethyl methanesulfonate in carenoxacin mesylate.