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HPLC法同时测定人血浆中齐多夫定和奈韦拉平浓度

Simultaneous Determination of Zidovudine and Nevirapine in Human Plasma by HPLC

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【作者】 李燕青黄民周波杜夏玮邹尚荣

【Author】 LI Yan-qing1,HUANG Min2,ZHOU Bo1,DU Xia-wei1,ZOU Shang-rong1(1.Deptartment of Pharmacy,Guangzhou No.8 People’s Hospital,Guangzhou,Guangdong 510060,China;2.Institute of Clinical Pharmacology,Sun Yat-sen University,Guangzhou,Guangdong 510080,China)

【机构】 广州市第八人民医院药剂科中山大学临床药理研究所

【摘要】 目的建立一种快速、灵敏并同时测定人体血浆中齐多夫定(AZT)和奈韦拉平(NVP)浓度的HPLC法。方法以Agilent XDB-C18反相柱(4.6 mm×150 mm,5μm)为色谱柱,以乙腈-水(18∶82)为流动相,流速为0.8 mL/min,检测波长:268 nm,柱温:30℃。以甲基叔丁基醚为提取剂,以甲硝唑为内标。结果 AZT高(4μg/mL)、中(1μg/mL)、低(0.1μg/mL)3个血药浓度的平均回收率RSD均<10%;线性范围为:0.05~5μg/mL,回归方程为y=4.329 3x+0.053 2,r2=0.999 2(n=7),分析方法的定量下限为0.05μg/mL。NVP高(40μg/mL)、中(10μg/mL)、低(1μg/L)3个浓度的平均方法回收率RSD均<10%;线性范围为:0.5~5μg/mL,回归方程为y=4.146 5x+0.062 9,r2=0.998 6(n=7),分析方法的定量下限为5μg/mL。结论该方法灵敏、准确、简单、快速,可用于同时使用AZT和NVP患者的临床血药浓度监测和药动学研究。

【Abstract】 Objective To establish a rapid and sensitive HPLC method for the simultaneous quantitative determination of zidovudine(AZT) and nevirapine(NVP) in human plasma.Methods AZT and NVP were extracted with methyl tert-butyl ether.The residues were analyzed on an RP-HPLC column(Agilent Eclipse XDB-C18 column,4.6 mm × 150 mm,5 μm) with the mobile phase consisted of acetonitrile-water(18∶ 82),with a flow rate of 0.8 mL/min,temperature of 30 ℃.The detection wavelength was 268 nm.Metronidazole was used as the internal standard.Results The average recovery rate RSD for AZT of 3 levels of concentration-high(4 μg / mL),medium(1 μg / mL) and low(0.1 μg / mL),was less than 10%.The calibration curves for AZT had good linearity,r2 = 0.999 2(n = 7),over the range of 0.05-5 μg / mL.The limits of quantitation was 0.05 μg / mL.Meanwhile,the average recovery rate RSD for NVP of 3 levels of concentration-high(40 μg / mL),medium(10 μg / mL) and low(1 μg / mL),was also less than 10%.The calibration curves for NVP had good linearity in the range of 0.5 ~ 50 μg / mL,r2 = 0.998 6(n = 7).The limit of quantitation was 0.5 μg / mL.Conclusion The method provides a sensitive,accurate,precise and reliable analytical procedure for the therapeutic drug monitoring of AZT and NVP simultaneously in clinical routine use and phamacokinetic studies.

【基金】 广州市医药卫生科技项目(编号:201102A213157);广东省医学科研基金(编号:A2013523)
  • 【分类号】R96
  • 【被引频次】5
  • 【下载频次】77
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