HPLC测定甲磺酸加雷沙星异构体

Determination of Enantiomers in Garenoxacin Mesylate by HPLC

摘要: 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，5 μm)，柱温：35 ℃，检测波长：278 nm，流速：1.0 mL·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0.005~0.151 μg·mL^-1内具有良好的线性(r>0.999)，定量限浓度为5 ng·mL^-1(相当于0.03%)，最低检测限为2.5 ng·mL^-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。

Abstract: 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.