Identification and structure elucidation of a new degradation impurity in the multi-component tablets of amlodipine besylate
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11310%2F19%3A10383778" target="_blank" >RIV/00216208:11310/19:10383778 - isvavai.cz</a>
Alternative codes found
RIV/61388963:_____/19:00501535
Result on the web
<a href="https://doi.org/10.1016/j.jpba.2018.07.040" target="_blank" >https://doi.org/10.1016/j.jpba.2018.07.040</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>
Alternative languages
Result language
angličtina
Original language name
Identification and structure elucidation of a new degradation impurity in the multi-component tablets of amlodipine besylate
Original language description
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.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
10406 - Analytical chemistry
Result continuities
Project
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Continuities
S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2019
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Journal of Pharmaceutical and Biomedical Analysis
ISSN
0731-7085
e-ISSN
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Volume of the periodical
162
Issue of the periodical within the volume
January
Country of publishing house
GB - UNITED KINGDOM
Number of pages
5
Pages from-to
112-116
UT code for WoS article
000449244100013
EID of the result in the Scopus database
2-s2.0-85053370147