Quantitation of bivalirudin, a novel anticoagulant peptide, in human plasma by LC-MS/MS: Method development, validation and application to pharmacokinetics
A rapid and sensitive method based on liquid chromatographtandem mass spectrometry (LC-MS/MS) for the determination of a novel anticoagulant peptide bivalirudin in human plasma has been developed and validated. Plasma samples were precipitated protein with acetonitrile and reextracted with dichlorom...
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Abstract | A rapid and sensitive method based on liquid chromatographtandem mass spectrometry (LC-MS/MS) for the determination of a novel anticoagulant peptide bivalirudin in human plasma has been developed and validated. Plasma samples were precipitated protein with acetonitrile and reextracted with dichloromethane, after which the analyte and triptorelin as an internal standard (IS) were separated on a 300SB-Cl8 column (150 mm x 4.6 mm i.d., 5 gm particle size) using 0.1% formic acid:methanol (45:55, v/v) as mobile phase. The triple-quadrupole mass spectrometer, equipped with electrospray ionization (ESI) interface, was operated in the positive ion mode, and the multiplereaction monitoring (MRM) transitions of bivalirudin and IS were at m/z 1091.0-650.4 and m/z656.5 - 249.3, respectively. The lower limit of quantification (LLOQ) was 1 ng/mL for 100 ng/mL plasma sample and the assay was linear over the concentration range 1 1000 ng/mL. The accuracy was within a range from -0.4% to 0.5% in terms of relative error (RE) and the intra- and inter-day precisions in terms of relative standard deviation (RSD) were 〈2.92 and 〈 3.36, respectively. The method was successfully applied to a pharmacokinetic study involving intravenous administration of bivalirudin (0.5 mg/kg) to Chinese volunteers. |
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AbstractList | A rapid and sensitive method based on liquid chromatographtandem mass spectrometry (LC-MS/MS) for the determination of a novel anticoagulant peptide bivalirudin in human plasma has been developed and validated. Plasma samples were precipitated protein with acetonitrile and reextracted with dichloromethane, after which the analyte and triptorelin as an internal standard (IS) were separated on a 300SB-Cl8 column (150 mm x 4.6 mm i.d., 5 gm particle size) using 0.1% formic acid:methanol (45:55, v/v) as mobile phase. The triple-quadrupole mass spectrometer, equipped with electrospray ionization (ESI) interface, was operated in the positive ion mode, and the multiplereaction monitoring (MRM) transitions of bivalirudin and IS were at m/z 1091.0-650.4 and m/z656.5 - 249.3, respectively. The lower limit of quantification (LLOQ) was 1 ng/mL for 100 ng/mL plasma sample and the assay was linear over the concentration range 1 1000 ng/mL. The accuracy was within a range from -0.4% to 0.5% in terms of relative error (RE) and the intra- and inter-day precisions in terms of relative standard deviation (RSD) were 〈2.92 and 〈 3.36, respectively. The method was successfully applied to a pharmacokinetic study involving intravenous administration of bivalirudin (0.5 mg/kg) to Chinese volunteers. A rapid and sensitive method based on liquid chromatography–tandem mass spectrometry (LC–MS/MS) for the determination of a novel anticoagulant peptide bivalirudin in human plasma has been developed and validated. Plasma samples were precipitated protein with acetonitrile and re-extracted with dichloromethane, after which the analyte and triptorelin as an internal standard (IS) were separated on a 300SB-C18 column (150 mm×4.6 mm i.d., 5 μm particle size) using 0.1% formic acid:methanol (45:55, v/v) as mobile phase. The triple-quadrupole mass spectrometer, equipped with electrospray ionization (ESI) interface, was operated in the positive ion mode, and the multiple-reaction monitoring (MRM) transitions of bivalirudin and IS were at m / z 1091.0→650.4 and m / z 656.5→249.3, respectively. The lower limit of quantification (LLOQ) was 1 ng/mL for 100 μL plasma sample and the assay was linear over the concentration range 1–1000 ng/mL. The accuracy was within a range from −0.4% to 0.5% in terms of relative error (RE) and the intra- and inter-day precisions in terms of relative standard deviation (RSD) were ≤2.92 and ≤3.36, respectively. The method was successfully applied to a pharmacokinetic study involving intravenous administration of bivalirudin (0.5 mg/kg) to Chinese volunteers. A rapid and sensitive method based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the determination of a novel anticoagulant peptide bivalirudin in human plasma has been developed and validated. Plasma samples were precipitated protein with acetonitrile and re-extracted with dichloromethane, after which the analyte and triptorelin as an internal standard (IS) were separated on a 300SB-C18 column (150 mm×4.6 mm i.d., 5 μm particle size) using 0.1% formic acid:methanol (45:55, v/v) as mobile phase. The triple-quadrupole mass spectrometer, equipped with electrospray ionization (ESI) interface, was operated in the positive ion mode, and the multiple-reaction monitoring (MRM) transitions of bivalirudin and IS were at / 1091.0→650.4 and / 656.5→249.3, respectively. The lower limit of quantification (LLOQ) was 1 ng/mL for 100 μL plasma sample and the assay was linear over the concentration range 1-1000 ng/mL. The accuracy was within a range from -0.4% to 0.5% in terms of relative error (RE) and the intra- and inter-day precisions in terms of relative standard deviation (RSD) were ≤2.92 and ≤3.36, respectively. The method was successfully applied to a pharmacokinetic study involving intravenous administration of bivalirudin (0.5 mg/kg) to Chinese volunteers. A rapid and sensitive method based on liquid chromatography–tandem mass spectrometry (LC–MS/MS) for the determination of a novel anticoagulant peptide bivalirudin in human plasma has been developed and validated. Plasma samples were precipitated protein with acetonitrile and re-extracted with dichloromethane, after which the analyte and triptorelin as an internal standard (IS) were separated on a 300SB-C18 column (150mm×4.6mm i.d., 5μm particle size) using 0.1% formic acid:methanol (45:55, v/v) as mobile phase. The triple-quadrupole mass spectrometer, equipped with electrospray ionization (ESI) interface, was operated in the positive ion mode, and the multiple-reaction monitoring (MRM) transitions of bivalirudin and IS were at m/z 1091.0→650.4 and m/z 656.5→249.3, respectively. The lower limit of quantification (LLOQ) was 1ng/mL for 100μL plasma sample and the assay was linear over the concentration range 1–1000ng/mL. The accuracy was within a range from −0.4% to 0.5% in terms of relative error (RE) and the intra- and inter-day precisions in terms of relative standard deviation (RSD) were ≤2.92 and ≤3.36, respectively. The method was successfully applied to a pharmacokinetic study involving intravenous administration of bivalirudin (0.5mg/kg) to Chinese volunteers. |
Author | Xiao-Jiao Li Yan-Tong Sun Lei Yin Xue-Ju Zhang Yan Yang J. Paul Fawcett Yi-Min Cui Jing-Kai Gu |
AuthorAffiliation | Clinical Pharmacology Center, Research Institute of Translational Medicine, The First Bethune Hospital of Jilin University,Changchun 130061, PR China Research Center for Drug Metabolism, College of Life Science, Jilin University, Changchun 130012, PR China School of Pharmacy, University of Otago, P.O. Box 56, Dunedin, New Zealand Department of Pharmacy Peking University First Hospital, Beijing 100034, PR China |
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BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29403790$$D View this record in MEDLINE/PubMed |
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Copyright | 2013 Xi'an Jiaotong University Copyright © Wanfang Data Co. Ltd. All Rights Reserved. 2013 Xi'an Jiaotong University 2013 |
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DocumentTitleAlternate | Quantitation of bivalirudin, a novel anticoagulant peptide, in human plasma by LC-MS/MS: Method development, validation and application to pharmacokinetics |
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Keywords | Bivalirudin Anticoagulant Human plasma Pharmacokinetics LC–MS/MS LC-MS/MS |
Language | English |
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Notes | 61-1484/R A rapid and sensitive method based on liquid chromatographtandem mass spectrometry (LC-MS/MS) for the determination of a novel anticoagulant peptide bivalirudin in human plasma has been developed and validated. Plasma samples were precipitated protein with acetonitrile and reextracted with dichloromethane, after which the analyte and triptorelin as an internal standard (IS) were separated on a 300SB-Cl8 column (150 mm x 4.6 mm i.d., 5 gm particle size) using 0.1% formic acid:methanol (45:55, v/v) as mobile phase. The triple-quadrupole mass spectrometer, equipped with electrospray ionization (ESI) interface, was operated in the positive ion mode, and the multiplereaction monitoring (MRM) transitions of bivalirudin and IS were at m/z 1091.0-650.4 and m/z656.5 - 249.3, respectively. The lower limit of quantification (LLOQ) was 1 ng/mL for 100 ng/mL plasma sample and the assay was linear over the concentration range 1 1000 ng/mL. The accuracy was within a range from -0.4% to 0.5% in terms of relative error (RE) and the intra- and inter-day precisions in terms of relative standard deviation (RSD) were 〈2.92 and 〈 3.36, respectively. The method was successfully applied to a pharmacokinetic study involving intravenous administration of bivalirudin (0.5 mg/kg) to Chinese volunteers. Bivalirudin;LC-MS/MS;Pharmacokinetics;Human plasma;Anticoagulant ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Xiao-Jiao Li and Yan-Tong Sun contributed equally to this work. |
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PublicationTitle | Journal of pharmaceutical analysis |
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PublicationYear | 2013 |
Publisher | Elsevier B.V Research Center for Drug Metabolism, College of Life Science, Jilin University, Changchun 130012, PR China%Clinical Pharmacology Center, Research Institute of Translational Medicine, The First Bethune Hospital of Jilin University,Changchun 130061, PR China%Research Center for Drug Metabolism, College of Life Science, Jilin University, Changchun 130012, PR China%School of Pharmacy, University of Otago, P.O.Box 56, Dunedin, New Zealand%Department of Pharmacy, Peking University First Hospital, Beijing 100034, PR China Clinical Pharmacology Center, Research Institute of Translational Medicine, The First Bethune Hospital of Jilin University,Changchun 130061, PR China Xi'an Jiaotong University |
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Snippet | A rapid and sensitive method based on liquid chromatographtandem mass spectrometry (LC-MS/MS) for the determination of a novel anticoagulant peptide... A rapid and sensitive method based on liquid chromatography–tandem mass spectrometry (LC–MS/MS) for the determination of a novel anticoagulant peptide... A rapid and sensitive method based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the determination of a novel anticoagulant peptide... |
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SubjectTerms | Anticoagulant Bivalirudin Human plasma LC-MS LC–MS/MS Pharmacokinetics S方法 人体血浆 应用 开发 抗凝血剂 药代动力学 验证 |
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Title | Quantitation of bivalirudin, a novel anticoagulant peptide, in human plasma by LC-MS/MS: Method development, validation and application to pharmacokinetics |
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