Sensitive, selective and rapid determination of bupropion and its major active metabolite, hydroxybupropion, in human plasma by LC-MS/MS: application to a bioequivalence study in healthy Indian subjects

Sensitive, selective and rapid determination of bupropion and its major active metabolite, hydroxybupropion, in human plasma by LC-MS/MS: application to a bioequivalence study in healthy Indian subjects
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DOI:
10.1002/bmc.1660
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发表时间:
2012-03-01
影响因子:
1.8
通讯作者:
Shrivastav, Pranav S.
Shrivastav, Pranav S.
中科院分区:
医学4区
文献类型:
--
作者:
Parekh, Jignesh M.;Sutariya, Dipen K.;Shrivastav, Pranav S.

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A sensitive, selective and rapid liquid chromatography tandem mass spectrometry (LC-MS/MS) method was developed for the simultaneous determination of bupropion (BUP) and its major active metabolite hydroxybupropion (HBUP) in human plasma. Separation of both the analytes and venlafaxine as internal standard (IS) from 50 mu L human plasma was carried out by solid-phase extraction. The chromatographic separation of the analytes was achieved on a Zorbax Eclipse XDB C18 (150 x 4.6mm, 5 mu m) analytical column using isocratic mobile phase consisting of 20 mm ammonium acetatemethanol (10:90, v/v), with a resolution factor of 3.5. The method was validated over a wide dynamic concentration range of 0.1350 ng/mL for BUP and 0.1600 ng/mL for HBUP. The matrix effect was assessed by post-column infusion and the mean process efficiency was 96.08 and 94.40% for BUP and HBUP, respectively. The method was successfully applied to a bioequivalence study of 150 mg BUP (test and reference) extended release tablet formulation in 12 healthy Indian male subjects under fed conditions. Copyright (C) 2011 John Wiley & Sons, Ltd.