Identification and structure elucidation of a new degradation impurity in the multi-component tablets of amlodipine besylate
Language English Country Great Britain, England Media print-electronic
Document type Journal Article
PubMed
30236818
DOI
10.1016/j.jpba.2018.07.040
PII: S0731-7085(18)31472-9
Knihovny.cz E-resources
- Keywords
- Amlodipine, Degradation impurity, Drug−excipient interactions, Structural elucidation, UHPLC–MS,
- MeSH
- Amlodipine chemistry MeSH
- Time Factors MeSH
- Chromatography, Reverse-Phase MeSH
- Chemistry, Pharmaceutical methods MeSH
- Drug Combinations MeSH
- Formaldehyde chemistry MeSH
- Spectrometry, Mass, Electrospray Ionization MeSH
- Hydrochlorothiazide chemistry MeSH
- Drug Contamination * MeSH
- Magnetic Resonance Spectroscopy MeSH
- Molecular Structure MeSH
- Excipients chemistry MeSH
- Drug Stability MeSH
- Valsartan chemistry MeSH
- Chromatography, High Pressure Liquid MeSH
- Publication type
- Journal Article MeSH
- Names of Substances
- Amlodipine MeSH
- Drug Combinations MeSH
- Formaldehyde MeSH
- Hydrochlorothiazide MeSH
- Excipients MeSH
- Valsartan MeSH
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-yl)-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.
References provided by Crossref.org
