HPLC测定甲磺酸加雷沙星异构体

Determination of Enantiomers in Garenoxacin Mesylate by HPLC

目的 建立甲磺酸加雷沙星异构体的HPLC检测方法。方法 Chiralpak AD-H色谱柱（250 mm×4.6 mm,5μm）,柱温：35℃,检测波长：278 nm,流速：1.0 m L·min-1,流动相：正己烷-异丙醇-甲醇-甲磺酸（70∶29∶1∶0.1）。结果 甲雷沙星及其异构体在0.005~0.151μg·m L-1内具有良好的线性（r〉0.999）,定量限浓度为5 ng·m L-1（相当于0.03%）,最低检测限为2.5 ng·m L-1（相当于0.015%）。结论 该方法简便、准确,具有良好的重现性和专属性。

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 m L·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·m L-1（r0.999）. The limit of quantification was 5 ng·m L-1（equivalent to 0.03%）. The minimum detection limit was 2.5 ng·m L-1（equivalent to 0.015%）. CONCLUTION The method is sample, accurate, reproducible and specific for determination of ethyl methanesulfonate in carenoxacin mesylate.