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Journal of Chinese Pharmaceutical Sciences ›› 2016, Vol. 25 ›› Issue (9): 676-682.DOI: 10.5246/jcps.2016.09.075

• Original articles • Previous Articles     Next Articles

Selective determination of tenofovir in human plasma by LC-MS-MS method

Xiang Xie1, Rui Zhou1, Peigen Zhou2, Peng Yu1*, Feng Gao2*   

  1. 1. School of Pharmaceutical Sciences, Central South University, Changsha 410013
    2. Department of Gastroenterology, Affiliated Wujin Hospital of Jiangsu University, Changzhou 213100
  • Received:2016-04-18 Revised:2016-05-19 Online:2016-09-28 Published:2016-06-12
  • Contact: Tel.: +86-0731-82650446, 13775103185, E-mail: peng.yu@csu.edu.cn, mycake00@163.com
  • Supported by:

    The Science and Technology Development Plan Project of Wujin District, Changzhou City, Jiangsu Province (Grant No. WS201413) and the Research Funds for the Teachers of Central South University (Grant No. 2014JSJJ028).

Abstract:

In the present study, we developed and validated a selective, specific and sensitive liquid chromatography-electrospray ionization mass spectrometry (LC-ESI-MS/MS) method for the determination of tenofovir in human plasma. Entecavir was used as an internal standard, and plasma samples were prepared by solid-phase extraction performed on Phenomenex Strata cartridges (30 mg). The mobile phase consisted of 10 mM ammonium acetate in water and methanol (60:40, v/v). The chromatographic separation was performed isocratically on a Phenomenex C18 (4.6 mm×150 mm, 5 μm), and analytes were analyzed in multiple reaction monitoring (MRM) mode with positive electrospray ionization (ESI) interface using the respective [M+H]+ ions, m/z 288.2→m/z 176.1 for tenofovir and m/z 278.1→m/z 152 for entecavir. The calibration curve (r2 = 0.9962) of tenofovir was established within the range of 4.096–1000 μg/L. The intra- and inter-day precisions were less than 10%. This validated method was successfully applied to a pharmacokinetic study in 12 healthy Chinese volunteers after the oral administration of tenofovir disoproxil fumarate.

Key words: LC-ESI-MS/MS, Tenofovir, Pharmacokinetic, Plasma

CLC Number: 

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