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引用本文:韦永爱,施宏刚,高鹍,吴海燕,李轩,董伟.HPLC测定甲磺酸加雷沙星异构体[J].中国现代应用药学,2015,32(7):840-843.
WEI Yongai,SHI Honggang,GAO Kun,WU Haiyan,LI Xuan,DONG Wei.Determination of Enantiomers in Garenoxacin Mesylate by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(7):840-843.
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HPLC测定甲磺酸加雷沙星异构体
韦永爱, 施宏刚, 高鹍, 吴海燕, 李轩, 董伟
天津市汉康医药生物技术有限公司,天津 300409
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。
关键词:  甲磺酸加雷沙星  异构体  高效液相色谱法
DOI:
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基金项目:
Determination of Enantiomers in Garenoxacin Mesylate by HPLC
WEI Yongai, SHI Honggang, GAO Kun, WU Haiyan, LI Xuan, DONG Wei
Tianjin Hankang Medicinal & Biological Technology Co.,Ltd., Tianjin 300409, China
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.
Key words:  garenoxacin mesylate  enantiomers  HPLC
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