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

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00216208:11110/24:10483692

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

10609 - Biochemical research methods

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2024

Kód důvěrnosti údajů

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

Název periodika

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

ISSN

1570-0232

e-ISSN

1873-376X

Svazek periodika

1245

Číslo periodika v rámci svazku

neuveden

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

12

Strana od-do

—

Kód UT WoS článku

001290183400001

EID výsledku v databázi Scopus

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