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AN UPLC METHOD FOR THE DETERMINATION OF SORAFENIB IN HUMAN PLASMA BY FLUORIMETRIC DETECTION WITH PRE-COLUMN DERIVATIZATION AND APPLICATION TO A PHARMACOKINETIC STUDY

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dc.contributor.authorTIRIS, GİZEM
dc.contributor.authorTekkeli, S. Evrim Kepekci
dc.contributor.authorÖnal, Cem
dc.contributor.authorCeylan, Burhan
dc.contributor.authorÖNAL, Armağan
dc.contributor.institutionauthorTIRIS, GİZEM
dc.date.accessioned2022-10-06T20:59:06Z
dc.date.available2022-10-06T20:59:06Z
dc.date.issued2022-01-01T00:00:00Z
dc.description.abstract© 2022, Publishing House of the Romanian Academy. All rights reserved.This research presents a new, sensitive and selective UPLC method with fluorometric detection for the determination of sorafenib in human plasma and application of the method to a pharmacokinetic study. Sorafenib was precolumn derivatized with 7-chloro-4-nitrobenzofurazan (NBD-Cl) and the separation of the fluorescent derivative was performed with a C18 column (50 mm x 2.1 mm, 1.7 µm) at 40ºC using a mobile phase composed of acetonitrile-0.1% trifluoroacetic acid in water (60:40, v/v) by isocratic elution with flow rate of 0.5 mL min−1. The injection volume was 7 µL. The method depends on the measurement of the derivative using fluorescence detection (λex = 398 nm, λem = 425 nm). The retention time of sorafenib was 3.10 ± 0.02 min. The novel method was validated in accordance with ICH criteria by studying on the parameters such as specificity, linearity, precision, accuracy and robustness. The method was determined to be linear in a concentration range of 0.25-10 µg mL−1 with the correlation coefficient of 0.9995. Limit of detection and quantitation were found to be 0.075 and 0.25 µg mL−1, respectively. Intraday and interday RSD values were less than 5.48%. The plasma concentration–time profile and pharmacokinetic parameters such as AUC0–t, AUC0–∞, Cmax, tmax, t1/2 were measured according to the assays. The proposed method is feasible to investigate the bioequivalence and bioavailability and routine analysis of the drug in plasma.
dc.identifier.citationTIRIS G., Tekkeli S. E. K. , Önal C., Ceylan B., ÖNAL A., -AN UPLC METHOD FOR THE DETERMINATION OF SORAFENIB IN HUMAN PLASMA BY FLUORIMETRIC DETECTION WITH PRE-COLUMN DERIVATIZATION AND APPLICATION TO A PHARMACOKINETIC STUDY-, Revue Roumaine de Chimie, cilt.67, sa.3, ss.217-224, 2022
dc.identifier.doi10.33224/rrch.2022.67.3.10
dc.identifier.scopus85136794323
dc.identifier.urihttp://hdl.handle.net/20.500.12645/31063
dc.titleAN UPLC METHOD FOR THE DETERMINATION OF SORAFENIB IN HUMAN PLASMA BY FLUORIMETRIC DETECTION WITH PRE-COLUMN DERIVATIZATION AND APPLICATION TO A PHARMACOKINETIC STUDY
dc.typeArticle
dspace.entity.typePublication
local.avesis.id01991054-dc77-4427-a31e-fa5c323703dd
local.publication.isinternational1
relation.isAuthorOfPublication1ab47475-d54a-4b46-a679-47fb775bc1ce
relation.isAuthorOfPublication.latestForDiscovery1ab47475-d54a-4b46-a679-47fb775bc1ce
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