HILIC-MS determination of dimethylamine in the active pharmaceutical ingredients and in the dosage forms of metformin

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F20%3A43923833" target="_blank" >RIV/60461373:22340/20:43923833 - isvavai.cz</a>

Výsledek na webu

<a href="https://www.sciencedirect.com/science/article/pii/S073170852031459X?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S073170852031459X?via%3Dihub</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.jpba.2020.113573" target="_blank" >10.1016/j.jpba.2020.113573</a>

Jazyk výsledku

angličtina

Název v původním jazyce

HILIC-MS determination of dimethylamine in the active pharmaceutical ingredients and in the dosage forms of metformin

Popis výsledku v původním jazyce

A sensitive and specific hydrophilic interaction chromatography (HILIC) method for the separation and determination of dimethylamine (DMA) in active pharmaceutical ingredients (APIs) and in dosage forms of metformin (MET) has been developed and validated. A feasible analytical method based on HILIC coupled with mass spectrometry detection (HILIC-MS) was established using a simple sample preparation. The separation of MET was achieved on a Cortecs HILIC column using a mixture of 10 mmol/L ammonium formate adjusted to pH 4.8 and acetonitrile (25:75, v/v) at 0.8 mL/min flow rate. The a single-quadrupole mass detector was operated in positive ion mode. Quadrupole mass analyser was employed in selected ion monitoring mode using a target ion at m/z = 46 as [M+H]+. The HILIC-MS method was validated as per International Council on Harmonization (ICH) guidelines in terms of linearity, limit of detection, limit of quantification, selectivity, accuracy, precision and intermediate precision. The main benefit of the HILIC-MS method is a simple sample pretreatment and a quick and sensitive HILIC-MS analysis. The method was demonstrated to be applicable for the determination of DMA in routine quality control evaluation of commercial samples of metformin of both API and dosage forms. The HILIC-MS method was developed as a simpler and faster alternative to compendial method for determination of DMA (as specific impurity F) in MET described in European Pharmacopoeia. © 2020 Elsevier B.V.

Název v anglickém jazyce

HILIC-MS determination of dimethylamine in the active pharmaceutical ingredients and in the dosage forms of metformin

Popis výsledku anglicky

A sensitive and specific hydrophilic interaction chromatography (HILIC) method for the separation and determination of dimethylamine (DMA) in active pharmaceutical ingredients (APIs) and in dosage forms of metformin (MET) has been developed and validated. A feasible analytical method based on HILIC coupled with mass spectrometry detection (HILIC-MS) was established using a simple sample preparation. The separation of MET was achieved on a Cortecs HILIC column using a mixture of 10 mmol/L ammonium formate adjusted to pH 4.8 and acetonitrile (25:75, v/v) at 0.8 mL/min flow rate. The a single-quadrupole mass detector was operated in positive ion mode. Quadrupole mass analyser was employed in selected ion monitoring mode using a target ion at m/z = 46 as [M+H]+. The HILIC-MS method was validated as per International Council on Harmonization (ICH) guidelines in terms of linearity, limit of detection, limit of quantification, selectivity, accuracy, precision and intermediate precision. The main benefit of the HILIC-MS method is a simple sample pretreatment and a quick and sensitive HILIC-MS analysis. The method was demonstrated to be applicable for the determination of DMA in routine quality control evaluation of commercial samples of metformin of both API and dosage forms. The HILIC-MS method was developed as a simpler and faster alternative to compendial method for determination of DMA (as specific impurity F) in MET described in European Pharmacopoeia. © 2020 Elsevier B.V.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

10406 - Analytical chemistry

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2020

Kód důvěrnosti údajů

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

Název periodika

Journal of Pharmaceutical and Biomedical Analysis

ISSN

0731-7085

e-ISSN

—

Svazek periodika

191

Číslo periodika v rámci svazku

NOV 30 2020

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

4

Strana od-do

113573

Kód UT WoS článku

000579528000016

EID výsledku v databázi Scopus

2-s2.0-85090221493