Development and Validation of a Rapid and Simple UHPLC-MS/MS Method for the Determination of Colchicine in Human Plasma

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14160%2F25%3A00143707" target="_blank" >RIV/00216224:14160/25:00143707 - isvavai.cz</a>

Výsledek na webu

<a href="https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/epdf/10.1002/bmc.70222?getft_integrator=clarivate&src=getftr&utm_source=clarivate" target="_blank" >https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/epdf/10.1002/bmc.70222?getft_integrator=clarivate&src=getftr&utm_source=clarivate</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1002/bmc.70222" target="_blank" >10.1002/bmc.70222</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Development and Validation of a Rapid and Simple UHPLC-MS/MS Method for the Determination of Colchicine in Human Plasma

Popis výsledku v původním jazyce

Colchicine is a naturally occurring alkaloid primarily derived from plants of the Colchicum genus, which is used to treat gout and serve as a frontline therapy for various inflammatory conditions, including familial Mediterranean fever. Although it is not recommended for routine therapeutic drug monitoring, there are situations where it may be beneficial, such as in dose adjustments. The present study introduces an LC-MS/MS method for quantifying colchicine in human plasma. A one-step extraction procedure employing an Ostro plate was applied, and the extracts were analyzed using gradient elution followed by detection on a mass spectrometer in multiple reaction monitoring mode. Our method offers several advantages, including a low sample volume and a run time of only 3 min. It demonstrates sufficient linearity to quantify low and high concentrations of colchicine in human plasma samples. The method was successfully validated in accordance with the ICH guideline M10 on bioanalytical method validation, covering selectivity, linearity, limit of quantification, accuracy, precision, dilution integrity, carry-over effect, matrix effects, extraction recovery, and stability over a concentration range of 0.05-100 ng/mL. The fully developed and validated method was applied to determine colchicine in plasma samples from patients diagnosed with familial Mediterranean fever.

Název v anglickém jazyce

Development and Validation of a Rapid and Simple UHPLC-MS/MS Method for the Determination of Colchicine in Human Plasma

Popis výsledku anglicky

Colchicine is a naturally occurring alkaloid primarily derived from plants of the Colchicum genus, which is used to treat gout and serve as a frontline therapy for various inflammatory conditions, including familial Mediterranean fever. Although it is not recommended for routine therapeutic drug monitoring, there are situations where it may be beneficial, such as in dose adjustments. The present study introduces an LC-MS/MS method for quantifying colchicine in human plasma. A one-step extraction procedure employing an Ostro plate was applied, and the extracts were analyzed using gradient elution followed by detection on a mass spectrometer in multiple reaction monitoring mode. Our method offers several advantages, including a low sample volume and a run time of only 3 min. It demonstrates sufficient linearity to quantify low and high concentrations of colchicine in human plasma samples. The method was successfully validated in accordance with the ICH guideline M10 on bioanalytical method validation, covering selectivity, linearity, limit of quantification, accuracy, precision, dilution integrity, carry-over effect, matrix effects, extraction recovery, and stability over a concentration range of 0.05-100 ng/mL. The fully developed and validated method was applied to determine colchicine in plasma samples from patients diagnosed with familial Mediterranean fever.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

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

Název periodika

BIOMEDICAL CHROMATOGRAPHY

ISSN

0269-3879

e-ISSN

1099-0801

Svazek periodika

39

Číslo periodika v rámci svazku

11

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

9

Strana od-do

1-9

Kód UT WoS článku

001605198800016

EID výsledku v databázi Scopus

2-s2.0-105016806969