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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Bibliographic Details
Published in:	Journal of pharmaceutical analysis Vol. 3; no. 1; pp. 36 - 44
Main Authors:	Gajula, Ramakrishna, Maddela, Rambabu, Babu Ravi, Vasu, Inamadugu, Jaswanth Kumar, Pilli, Nageswara Rao
Format:	Journal Article
Language:	English
Published:	China Elsevier B.V 01-02-2013 Wellquest Clinical Research Laboratories, Ramanthapur, Hyderabad 500013, India Xi'an Jiaotong University
Subjects:	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 Duloxetine in human plasma Solid-phase extraction (SPE) Method validation Liquid chromatography–tandem mass spectrometry Pharmacokinetic studies Liquid chromatographytandem mass spectrometry
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Summary:	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.
Bibliography:	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
ISSN:	2095-1779 2214-0883
DOI:	10.1016/j.jpha.2012.09.004