Simultaneous determination of lamivudine,stavudine and nevirapine in human plasma by LC–MS/MS and its application to pharmacokinetic study in clinic |
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Authors: | Zhou Li Cungang Ding Qinghua Ge Zhen Zhou Xiaojin Zhi Xiaofen Liu |
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Institution: | Shanghai Institute of Pharmaceutical Industry, National Pharmaceutical Engineering and Research Center, 1111 Halei Road, Zhangjiang Hi‐Tech Park, Shanghai 201203, People's Republic of China |
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Abstract: | A new high‐throughput LC–MS/MS method for the simultaneous determination of lamivudine (3TC), stavudine (d4T) and nevirapine (NVP) in human plasma is presented, with zidovudine as an internal standard. The analytes were extracted from plasma by protein precipitation and only 150 μL plasma was needed. Chromatographic separation was achieved on a Shiseido C8 column (150 × 2.0 mm, 5 μm) with a total run time of 6 min. A tandem mass spectrometric detection was conducted using multiple reaction monitoring under positive ionization mode with an electrospray ionization interface. The method was developed and validated over the concentration range of 25–5000 ng/mL for 3TC and NVP and 20–4000 ng/mL for d4T. The method was validated in terms of intra‐ and inter‐day precision (≤8.6%), accuracy (within ± 8.4%), linearity and specificity. The method has been successfully applied to the pharmacokinetic study of a combination treatment of 300 mg lamivudine, 30 mg stavudine and 200 mg nevirapine in 22 healthy male volunteers under fasting conditions. Copyright © 2010 John Wiley & Sons, Ltd. |
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Keywords: | lamivudine stavudine nevirapine LC– MS/MS pharmacokinetic study |
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