Validation of a method for the determination of Aderamastat (FP-025) in K2EDTA human plasma by LC-MS/MS

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064190%3A_____%2F24%3A10001312" target="_blank" >RIV/00064190:_____/24:10001312 - isvavai.cz</a>

Alternative codes found

RIV/00216208:11110/24:10483692

Result on the web

<a href="https://doi.org/10.1016/j.jchromb.2024.124244" target="_blank" >https://doi.org/10.1016/j.jchromb.2024.124244</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.jchromb.2024.124244" target="_blank" >10.1016/j.jchromb.2024.124244</a>

Result language

angličtina

Original language name

Validation of a method for the determination of Aderamastat (FP-025) in K2EDTA human plasma by LC-MS/MS

Original language description

Aderamastat (FP-025) is a small molecule, selective matrix metalloproteinase (MMP)-12 inhibitor, under development for respiratory conditions which may include chronic inflammatory airway diseases and pulmonary fibrosis. To support evaluation of the pharmacokinetic parameters of Aderamastat in humans, we developed and validated a high-performance liquid chromatography tandem mass spectrometry (LC-MS/MS) analytical method for the quantification of Aderamastat in human plasma. This assay was validated in compliance with the Food and Drug Administration (FDA) Good Laboratory Practice Regulations (GLP) and European Medicines Agency (EMA) guidelines. K2EDTA human plasma samples were spiked with internal standard, processed by liquid-liquid extraction, and analyzed using reversed-phase HPLC with Turbo Ion Spray (R) MS/MS detection. Separation was done using a chromatographic gradient on 5 mu m C6-Phenyl 110 &amp; Aring;, 50*2 mm analytical column at a temperature of 35 degrees C. The LC-MS/MS bioanalytical method, developed by QPS Taiwan to determine the concentration of Aderamastat in K2EDTA human plasma, was successfully validated with respect to linearity, sensitivity, accuracy, precision, dilution, selectivity, hemolyzed plasma, lipemic plasma, batch size, recovery, matrix effect, and carryover. These data indicate that the method for determination of Aderamastat concentrations in human K2EDTA plasma can be used in pharmacokinetics studies and subsequent clinical trials with Aderamastat. Authors declare that, this novel data is not published and not under consideration for publication by another journal than this journal. All data will be made available on request.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

10609 - Biochemical research methods

Project

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Continuities

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Publication year

2024

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

ISSN

1570-0232

e-ISSN

1873-376X

Volume of the periodical

1245

Issue of the periodical within the volume

neuveden

Country of publishing house

NL - THE KINGDOM OF THE NETHERLANDS

Number of pages

12

Pages from-to

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UT code for WoS article

001290183400001

EID of the result in the Scopus database

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