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LC-MS/MS法测定人血浆中安妥沙星的浓度及盐酸安妥沙星片在健康人体的药代动力学研究

李汇涓 孙鲁宁 张宏文 应玉雯 焦慧文 马云苏 谢利军 陈娟 欧宁

中国临床药理学杂志2018,Vol.34Issue(7):866-869,4.
中国临床药理学杂志2018,Vol.34Issue(7):866-869,4.DOI:10.13699/j.cnki.1001-6821.2018.07.038

LC-MS/MS法测定人血浆中安妥沙星的浓度及盐酸安妥沙星片在健康人体的药代动力学研究

Determination the concentration of antofloxacin in human plasma by LC-MS /MS and its application in the pharmacokinetic study of antofloxacin hydrochloride

李汇涓 1孙鲁宁 2张宏文 1应玉雯 1焦慧文 1马云苏 1谢利军 1陈娟 1欧宁1

作者信息

  • 1. 南京医科大学第一附属医院临床药理研究室,南京210029
  • 2. 广西壮族自治区人民医院药物临床试验机构办公室,南宁530021
  • 折叠

摘要

Abstract

Objective To develop a LC-MS/MS method for the determination of antofloxacin in human plasma and to study the pharmacokinetic characteristics of antofloxacin after oral administration of antofloxacin hydrochloride tablets.Methods The samples were precipitated by acetonitrile and ornidazole was selected as the internal standard.The separation was carried on a Agilent Poroshell 120 SB-C18(2.1 mm × 50 mm,2.7 μm) column with a mobile phase of acetonitrile:5 mmol · L-1 ammonium formate (containing 0.1% formic acid) =12∶88 at a flow of 0.4 mL · min-1 12 healthy subjects were given orally single dose of antofloxacin hydrochloride 400 mg dose,blood samples were collected at different time points,the concentration of antofloxacin in human plasma was measured,and the main pharmacokinetic parameters were calculated by DAS 2.1.1 and Excel 2003.Results All the analytes showed good linearity over their concentration ranges on 0.01-15.00 μg · mL-1 The accuracy,inter-run and intra-run precisions were all below 15%.Analytes were stable during the study.The main pharmacokinetic parameters after antofloxacin 400 mg single drug administration:Cmax was (3.57 ±0.54) μg · mL-1,tmaxwas (2.25 ±0.92) h,t1/2 was (11.76 ± 1.64) h,AUC0-1 was (60.38 ± 7.47)μg · mL-1 · h.Conclusion This method can be used to determine the concentration of antofloxacin in human plasma and to study the pharmacokinetics of antofloxacin hydrochloride tablets.

关键词

安妥沙星/LC-MS/MS法/药代动力学

Key words

antofloxacin/LC-MS/MS method/pharmacokinetics

分类

医药卫生

引用本文复制引用

李汇涓,孙鲁宁,张宏文,应玉雯,焦慧文,马云苏,谢利军,陈娟,欧宁..LC-MS/MS法测定人血浆中安妥沙星的浓度及盐酸安妥沙星片在健康人体的药代动力学研究[J].中国临床药理学杂志,2018,34(7):866-869,4.

基金项目

国家自然科学基金资助项目(81503160) (81503160)

中国临床药理学杂志

OA北大核心CSCDCSTPCD

1001-6821

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