A rapid and sensitive liquid chromatography-tandem mass spectrometric assay for duloxetine in human plasma： Its pharmacokinetic application
This paper describes a simple, rapid and sensitive liquid chromatography tandem mass spectrometry assay for the determination of duloxetine in human plasma. A duloxetine stable labeled isotope （duloxetine ds） was used as an internal standard. Analyte and the internal standard were extracted from 100...
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| Published in: | Journal of pharmaceutical analysis Vol. 3; no. 1; pp. 36 - 44 |
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| Main Authors: | , , , , |
| Format: | Journal Article |
| Language: | English |
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China
Elsevier B.V
01-02-2013
Wellquest Clinical Research Laboratories, Ramanthapur, Hyderabad 500013, India Xi'an Jiaotong University |
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| Abstract | This paper describes a simple, rapid and sensitive liquid chromatography tandem mass spectrometry assay for the determination of duloxetine in human plasma. A duloxetine stable labeled isotope （duloxetine ds） was used as an internal standard. Analyte and the internal standard were extracted from 100 btL of human plasma via solid phase extraction technique using Oasis HLB cartridges. The chromatographic separation was achieved on a Cl8 column by using a mixture of acetonitrile 5 mM ammonium acetate buffer （83：17, v/v） as the mobile phase at a flow rate of 0.9 mL/min. The calibration curve obtained was linear （r2≥0.99） over the concentration range of 0.05 101 ng/mL. Multiple-reaction monitoring mode （MRM） was used for quantification of ion transitions at rn/z 298.3/154.1 and 303.3/159.1 for the drug and the internal standard, respectively. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.5 min for each sample made it possible to analyze more than 300 plasma samples per day. The proposed method was found to be applicable to clinical studies. |
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| AbstractList | This paper describes a simple, rapid and sensitive liquid chromatography-tandem mass spectrometry assay for the determination of duloxetine in human plasma. A duloxetine stable labeled isotope (duloxetine d
) was used as an internal standard. Analyte and the internal standard were extracted from 100 μL of human plasma
solid phase extraction technique using Oasis HLB cartridges. The chromatographic separation was achieved on a C
column by using a mixture of acetonitrile-5 mM ammonium acetate buffer (83:17, v/v) as the mobile phase at a flow rate of 0.9 mL/min. The calibration curve obtained was linear (
≥0.99) over the concentration range of 0.05-101 ng/mL. Multiple-reaction monitoring mode (MRM) was used for quantification of ion transitions at
/
298.3/154.1 and 303.3/159.1 for the drug and the internal standard, respectively. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.5 min for each sample made it possible to analyze more than 300 plasma samples per day. The proposed method was found to be applicable to clinical studies. This paper describes a simple, rapid and sensitive liquid chromatography tandem mass spectrometry assay for the determination of duloxetine in human plasma. A duloxetine stable labeled isotope （duloxetine ds） was used as an internal standard. Analyte and the internal standard were extracted from 100 btL of human plasma via solid phase extraction technique using Oasis HLB cartridges. The chromatographic separation was achieved on a Cl8 column by using a mixture of acetonitrile 5 mM ammonium acetate buffer （83：17, v/v） as the mobile phase at a flow rate of 0.9 mL/min. The calibration curve obtained was linear （r2≥0.99） over the concentration range of 0.05 101 ng/mL. Multiple-reaction monitoring mode （MRM） was used for quantification of ion transitions at rn/z 298.3/154.1 and 303.3/159.1 for the drug and the internal standard, respectively. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.5 min for each sample made it possible to analyze more than 300 plasma samples per day. The proposed method was found to be applicable to clinical studies. This paper describes a simple, rapid and sensitive liquid chromatography–tandem mass spectrometry assay for the determination of duloxetine in human plasma. A duloxetine stable labeled isotope (duloxetine d5) was used as an internal standard. Analyte and the internal standard were extracted from 100μL of human plasma via solid phase extraction technique using Oasis HLB cartridges. The chromatographic separation was achieved on a C18 column by using a mixture of acetonitrile–5mM ammonium acetate buffer (83:17, v/v) as the mobile phase at a flow rate of 0.9mL/min. The calibration curve obtained was linear (r2≥0.99) over the concentration range of 0.05–101ng/mL. Multiple-reaction monitoring mode (MRM) was used for quantification of ion transitions at m/z 298.3/154.1 and 303.3/159.1 for the drug and the internal standard, respectively. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.5min for each sample made it possible to analyze more than 300 plasma samples per day. The proposed method was found to be applicable to clinical studies. This paper describes a simple, rapid and sensitive liquid chromatography–tandem mass spectrometry assay for the determination of duloxetine in human plasma. A duloxetine stable labeled isotope (duloxetine d 5 ) was used as an internal standard. Analyte and the internal standard were extracted from 100 μL of human plasma via solid phase extraction technique using Oasis HLB cartridges. The chromatographic separation was achieved on a C 18 column by using a mixture of acetonitrile–5 mM ammonium acetate buffer (83:17, v/v) as the mobile phase at a flow rate of 0.9 mL/min. The calibration curve obtained was linear ( r 2 ≥0.99) over the concentration range of 0.05–101 ng/mL. Multiple-reaction monitoring mode (MRM) was used for quantification of ion transitions at m / z 298.3/154.1 and 303.3/159.1 for the drug and the internal standard, respectively. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.5 min for each sample made it possible to analyze more than 300 plasma samples per day. The proposed method was found to be applicable to clinical studies. |
| Author | Ramakrishna Gajula Rambabu Maddela Vasu Babu Ravi Jaswanth Kumar-Inamadugu Nageswara Rao Pilli |
| AuthorAffiliation | Wellquest Clinical Research Laboratories, Ramanthapur, Hyderabad 500013, India |
| AuthorAffiliation_xml | – name: Wellquest Clinical Research Laboratories, Ramanthapur, Hyderabad 500013, India |
| Author_xml | – sequence: 1 givenname: Ramakrishna surname: Gajula fullname: Gajula, Ramakrishna – sequence: 2 givenname: Rambabu surname: Maddela fullname: Maddela, Rambabu – sequence: 3 givenname: Vasu surname: Babu Ravi fullname: Babu Ravi, Vasu – sequence: 4 givenname: Jaswanth Kumar surname: Inamadugu fullname: Inamadugu, Jaswanth Kumar email: jaswanth.kumarreddy@gmail.com – sequence: 5 givenname: Nageswara Rao surname: Pilli fullname: Pilli, Nageswara Rao email: nagr_80@yahoo.co.in |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29403794$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1186_s40780_021_00189_9 crossref_primary_10_1002_bmc_3024 crossref_primary_10_1002_bmc_4883 crossref_primary_10_1016_j_jpha_2013_11_002 crossref_primary_10_12793_tcp_2022_30_e10 crossref_primary_10_1002_bmc_2936 crossref_primary_10_3389_fpain_2023_1190440 crossref_primary_10_1016_j_jpha_2023_07_004 crossref_primary_10_4155_bio_2021_0185 |
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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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| Keywords | Duloxetine in human plasma Solid-phase extraction (SPE) Method validation Liquid chromatography–tandem mass spectrometry Pharmacokinetic studies Liquid chromatographytandem mass spectrometry |
| Language | English |
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| Notes | This paper describes a simple, rapid and sensitive liquid chromatography tandem mass spectrometry assay for the determination of duloxetine in human plasma. A duloxetine stable labeled isotope （duloxetine ds） was used as an internal standard. Analyte and the internal standard were extracted from 100 btL of human plasma via solid phase extraction technique using Oasis HLB cartridges. The chromatographic separation was achieved on a Cl8 column by using a mixture of acetonitrile 5 mM ammonium acetate buffer （83：17, v/v） as the mobile phase at a flow rate of 0.9 mL/min. The calibration curve obtained was linear （r2≥0.99） over the concentration range of 0.05 101 ng/mL. Multiple-reaction monitoring mode （MRM） was used for quantification of ion transitions at rn/z 298.3/154.1 and 303.3/159.1 for the drug and the internal standard, respectively. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.5 min for each sample made it possible to analyze more than 300 plasma samples per day. The proposed method was found to be applicable to clinical studies. 61-1484/R Duloxetine in humanplasma;Solid-phase extraction（SPE）;Liquidchromatography-tandem mass spectro-metry;Method validation;Pharmacokinetic studies ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
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| PublicationTitle | Journal of pharmaceutical analysis |
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| Publisher | Elsevier B.V Wellquest Clinical Research Laboratories, Ramanthapur, Hyderabad 500013, India Xi'an Jiaotong University |
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| Snippet | This paper describes a simple, rapid and sensitive liquid chromatography tandem mass spectrometry assay for the determination of duloxetine in human plasma. A... This paper describes a simple, rapid and sensitive liquid chromatography–tandem mass spectrometry assay for the determination of duloxetine in human plasma. A... This paper describes a simple, rapid and sensitive liquid chromatography-tandem mass spectrometry assay for the determination of duloxetine in human plasma. A... |
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| SubjectTerms | Duloxetine in human plasma Liquid chromatography–tandem mass spectrometry Method validation Pharmacokinetic studies Solid-phase extraction (SPE) 串联质谱法 人血浆 力学应用 固相萃取技术 度洛西汀 测定 液相色谱 灵敏 |
| Title | A rapid and sensitive liquid chromatography-tandem mass spectrometric assay for duloxetine in human plasma： Its pharmacokinetic application |
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