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

0501535 - ÚOCHB 2020 RIV NL eng J - Journal Article
Gibala, P. - Douša, M. - Kalužíková, Aneta - Tkadlecová, M. - Štefko, M. - Kalášek, S. - Břicháč, J.
Identification and structure elucidation of a new degradation impurity in the multi-component tablets of amlodipine besylate.
Journal of Pharmaceutical and Biomedical Analysis. Roč. 162, Jan 5 (2019), s. 112-116. ISSN 0731-7085. E-ISSN 1873-264X
Institutional support: RVO:61388963
Keywords : drug-excipient interactions * amlodipine * degradation impurity * structural elucidation * UHPLC-MS
OECD category: Analytical chemistry
Impact factor: 3.209, year: 2019
Method of publishing: Limited access
https://www.sciencedirect.com/science/article/abs/pii/S0731708518314729?via%3Dihub

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.
Permanent Link: http://hdl.handle.net/11104/0296272