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A New LC–MS–MS Method for Quantitative Analysis of Adefovir, and Its Use for Pharmacokinetic Studies in Healthy Chinese Volunteers

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Abstract

A rapid and sensitive liquid chromatographic–tandem mass spectrometric method for analysis of adefovir in human plasma has been developed and validated. After protein precipitation and evaporation, 10 μL supernatant was injected for reversed-phase LC separation. Adefovir and the internal standard (acyclovir) were monitored in selected reaction monitoring (SRM) mode at m/z 274.10 → 256.00 and 226.10 → 152.00, respectively. The calibration plot was linear over the concentration range 0.5–100 ng mL−1, and correlation coefficients were >0.999. Mean intra-day and inter-day accuracy ranged from 89.43 to 93.20% and from 91.40 to 95.57%, respectively, and mean intra-day and inter-day precision was between 2.40 and 7.66% and between 5.60 and 10.47%, respectively. The method was successfully applied to a Phase I pharmacokinetic study of adefovir after oral administration of adefovir dipivoxil capsules at doses of 5, 10, and 20 mg to twenty-four healthy Chinese volunteers.

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Acknowledgements

The kind supply of adefovir by Wuzhongsuyao Pharmaceutical Developments Co. Ltd (Jiangsu, China) is deeply appreciated. Technical assistance from Miss Yan Liang is highly appreciated. This work was supported by Jiangsu Nature Science Fund (BK2006152).

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Authors and Affiliations

  1. Key Laboratory of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University, 210009, Nanjing, China

    Hai-Tang Xie, Guang-Ji Wang, Mei-Juan Xu, Yuan-Wei Jia, Hao Li, Jian-Guo Sun & Peng Li

  2. Anhui Provincial Center for Drug Clinical Evaluation, Yijishan Hospital of Wannan Medical College, 241001, Wuhu, China

    Hai-Tang Xie & Yuan-Wei Jia

  3. Department of Clinical Pharmacology, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, 210029, Nanjing, China

    Mei-Juan Xu

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  1. Hai-Tang Xie
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  2. Guang-Ji Wang
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  4. Yuan-Wei Jia
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Correspondence to Guang-Ji Wang.

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Xie, HT., Wang, GJ., Xu, MJ. et al. A New LC–MS–MS Method for Quantitative Analysis of Adefovir, and Its Use for Pharmacokinetic Studies in Healthy Chinese Volunteers. Chroma 71, 587–593 (2010). https://doi.org/10.1365/s10337-010-1474-4

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  • DOI: https://doi.org/10.1365/s10337-010-1474-4

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