Identification and structure elucidation of a new degradation impurity in the multi-component tablets of amlodipine besylate

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61388963%3A_____%2F19%3A00501535" target="_blank" >RIV/61388963:_____/19:00501535 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11310/19:10383778

Výsledek na webu

<a href="https://www.sciencedirect.com/science/article/abs/pii/S0731708518314729?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/abs/pii/S0731708518314729?via%3Dihub</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.jpba.2018.07.040" target="_blank" >10.1016/j.jpba.2018.07.040</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Identification and structure elucidation of a new degradation impurity in the multi-component tablets of amlodipine besylate

Popis výsledku v původním jazyce

New unknown impurity at m/z 421.15 was observed during the accelerated stability analysis (40 C/75% relative humidity) in the multi-component tablets of amlodipine besylate by reversed phase ultra-high performance liquid chromatography-mass spectrometry (UHPLC-MS). UHPLC-MS and nuclear magnetic resonance (NMR) techniques were employed to identify and fully characterize the degradation compound. The degradation product was unambiguously identified as 3-ethyl 5-methyl 4(2-chlorophenyl)-6-methyl-2-(morpholin-2-yI)-1,4-dihydropyridine-3,5-dicarboxylate and mechanism of its formation was proposed. It was confirmed that the degradation product was formed by the reaction of amlodipine with formaldehyde originating from the excipients present in the dosage form.

Název v anglickém jazyce

Identification and structure elucidation of a new degradation impurity in the multi-component tablets of amlodipine besylate

Popis výsledku anglicky

New unknown impurity at m/z 421.15 was observed during the accelerated stability analysis (40 C/75% relative humidity) in the multi-component tablets of amlodipine besylate by reversed phase ultra-high performance liquid chromatography-mass spectrometry (UHPLC-MS). UHPLC-MS and nuclear magnetic resonance (NMR) techniques were employed to identify and fully characterize the degradation compound. The degradation product was unambiguously identified as 3-ethyl 5-methyl 4(2-chlorophenyl)-6-methyl-2-(morpholin-2-yI)-1,4-dihydropyridine-3,5-dicarboxylate and mechanism of its formation was proposed. It was confirmed that the degradation product was formed by the reaction of amlodipine with formaldehyde originating from the excipients present in the dosage form.

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

2019

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

162

Číslo periodika v rámci svazku

Jan 5

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

5

Strana od-do

112-116

Kód UT WoS článku

000449244100013

EID výsledku v databázi Scopus

2-s2.0-85053370147