| Analysis of second-generation antidepressant drug, sertraline and its active metabolite, N-desmethyl sertraline in human plasma by a sensitive and selective liquid chromatography-tandem mass spectrometry method. | |
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MedLine Citation:
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PMID: 19109078 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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A precise, sensitive and high throughput liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for simultaneous determination of sertraline (SER) and its primary metabolite, N-desmethyl sertraline (NDS) in human plasma is developed and validated. The analytes and the internal standard-fluoxetine were extracted from 300 microL aliquots of human plasma via liquid-liquid extraction in methyl tert-butyl ether. Chromatographic separation was achieved in a run time of 2.5 min on a Betasil C8 column (100 mm x 2 .1 mm, 5 microm) under isocratic conditions. Detection of analytes and IS was done by tandem mass spectrometry, operating in positive ion and multiple reaction monitoring (MRM) acquisition mode. The protonated precursor to product ion transitions monitored for SER, NDS and IS were m/z 306.2-->159.0, 292.1-->159.0 and 310.6-->148.4, respectively. The method was fully validated for its sensitivity, selectivity, linearity, accuracy and precision, matrix effect, stability study and dilution integrity. A linear dynamic range of 0.5-150 ng/mL was established for both the analytes with mean correlation coefficient (r) of 0.9993 and 0.9980, respectively. The intra-batch and inter-batch precision (%CV) across five quality control levels was <or=10.4% for both the analytes. The method was successfully applied to a bioequivalence study of 100mg sertraline tablet formulation in 32 healthy Indian male subjects under fasting condition. |
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Authors:
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Bhavin N Patel; Naveen Sharma; Mallika Sanyal; Pranav S Shrivastav |
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Publication Detail:
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Type: Journal Article Date: 2008-12-09 |
Journal Detail:
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Title: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Volume: 877 ISSN: 1570-0232 ISO Abbreviation: J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. Publication Date: 2009 Jan |
Date Detail:
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Created Date: 2009-01-12 Completed Date: 2009-04-28 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101139554 Medline TA: J Chromatogr B Analyt Technol Biomed Life Sci Country: Netherlands |
Other Details:
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Languages: eng Pagination: 221-9 Citation Subset: IM |
Affiliation:
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Chemistry Department, School of Sciences, Gujarat University, Navrangpura, Ahmedabad 380009, Gujarat, India. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Antidepressive Agents, Second-Generation
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blood*,
pharmacokinetics Chromatography, Liquid* Drug Stability Fluoxetine / analysis Humans Linear Models Male Reference Standards Reproducibility of Results Sensitivity and Specificity Sertraline / analogs & derivatives*, blood*, pharmacokinetics Tandem Mass Spectrometry* |
| Chemical | |
Reg. No./Substance:
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0/Antidepressive Agents, Second-Generation; 54910-89-3/Fluoxetine; 79617-96-2/Sertraline; 87857-41-8/desmethylsertraline |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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