| 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. | |
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MedLine Citation:
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PMID: 22789899 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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%. |
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Authors:
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Jignesh M Parekh; Dhaval K Shah; Mallika Sanyal; Manish Yadav; Pranav S Shrivastav |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial Date: 2012-06-26 |
Journal Detail:
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Title: Journal of pharmaceutical and biomedical analysis Volume: 70 ISSN: 1873-264X ISO Abbreviation: J Pharm Biomed Anal Publication Date: 2012 Nov |
Date Detail:
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Created Date: 2012-09-14 Completed Date: 2013-02-07 Revised Date: 2013-06-18 |
Medline Journal Info:
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Nlm Unique ID: 8309336 Medline TA: J Pharm Biomed Anal Country: England |
Other Details:
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Languages: eng Pagination: 462-70 Citation Subset: IM |
Copyright Information:
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Copyright © 2012 Elsevier B.V. All rights reserved. |
Affiliation:
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Chemistry Department, Kadi Sarva Vishwavidyalaya, Sarva Vidyalaya Campus, Sector 15/23, Gandhinagar 382015, Gujarat, India. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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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:
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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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