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

Result code in 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>

Result on the web

<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>

Result language

angličtina

Original language name

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

Original language description

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.

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

—

OECD FORD branch

10406 - Analytical chemistry

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2020

Confidentiality

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

Name of the periodical

Journal of Pharmaceutical and Biomedical Analysis

ISSN

0731-7085

e-ISSN

—

Volume of the periodical

191

Issue of the periodical within the volume

NOV 30 2020

Country of publishing house

GB - UNITED KINGDOM

Number of pages

4

Pages from-to

113573

UT code for WoS article

000579528000016

EID of the result in the Scopus database

2-s2.0-85090221493