Document Detail


Development of an SPE-LC-MS/MS method for simultaneous quantification of bosentan and its active metabolite hydroxybosentan in human plasma to support a bioequivalence study.
MedLine Citation:
PMID:  22789899     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A highly sensitive, selective and rapid bioanalytical method has been developed for the simultaneous determination of bosentan and hydroxybosentan in human plasma by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The analytes and their deuterated analogs were quantitatively extracted from 100 μL human plasma by solid phase extraction. The chromatographic separation of analytes was achieved on a Thermo Hypurity C18 (100 mm × 4.6 mm, 5 μ) analytical column with a resolution factor of 2.4 under isocratic conditions. The method was validated over a dynamic concentration range of 0.4-1600 ng/mL for bosentan and 0.2-250 ng/mL for hydroxybosentan. Ion-suppression effects were investigated by post-column infusion of analytes. The precision (%CV) values for the calculated slopes of calibration curves, which would reflect the relative matrix effect, were less than 1.2% for both the analytes. The intra-batch and inter-batch precision (%CV) across quality control levels was ≤4.0% and the mean relative recovery was >94% for both the analytes. The method was successfully applied to a bioequivalence study of 125 mg tablet formulation (test and reference) in 12 healthy Indian male subjects under fasting condition. The ratios of mean log-transformed values of C(max), AUC(0-t) and AUC(0-inf) and their 90% CIs varied from 91.3 to 104.7%. The percentage change for incurred sample reanalysis (ISR) was within ±13.0%.
Authors:
Jignesh M Parekh; Dhaval K Shah; Mallika Sanyal; Manish Yadav; Pranav S Shrivastav
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial     Date:  2012-06-26
Journal Detail:
Title:  Journal of pharmaceutical and biomedical analysis     Volume:  70     ISSN:  1873-264X     ISO Abbreviation:  J Pharm Biomed Anal     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-09-14     Completed Date:  2013-02-07     Revised Date:  2013-06-18    
Medline Journal Info:
Nlm Unique ID:  8309336     Medline TA:  J Pharm Biomed Anal     Country:  England    
Other Details:
Languages:  eng     Pagination:  462-70     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Elsevier B.V. All rights reserved.
Affiliation:
Chemistry Department, Kadi Sarva Vishwavidyalaya, Sarva Vidyalaya Campus, Sector 15/23, Gandhinagar 382015, Gujarat, India.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Antihypertensive Agents / administration & dosage,  blood*,  pharmacokinetics*
Area Under Curve
Biotransformation
Calibration
Chromatography, High Pressure Liquid* / standards
Chromatography, Reverse-Phase* / standards
Cross-Over Studies
Fasting / blood
Half-Life
Humans
Hydroxylation
India
Male
Metabolic Clearance Rate
Reference Standards
Reproducibility of Results
Sensitivity and Specificity
Solid Phase Extraction* / standards
Sulfonamides / administration & dosage,  blood*,  pharmacokinetics*
Tablets
Tandem Mass Spectrometry* / standards
Therapeutic Equivalency
Young Adult
Chemical
Reg. No./Substance:
0/Antihypertensive Agents; 0/Sulfonamides; 0/Tablets; Q326023R30/bosentan

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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