Esterification of Ibuprofen in Soft Gelatin Capsules Formulations-Identification, Synthesis and Liquid Chromatography Separation of the Degradation Products
Jazyk angličtina Země Spojené státy americké Médium print
Typ dokumentu časopisecké články
PubMed
28505277
DOI
10.1093/chromsci/bmx036
PII: 3823327
Knihovny.cz E-zdroje
- MeSH
- esterifikace MeSH
- ibuprofen analýza chemie izolace a purifikace MeSH
- polysorbáty MeSH
- referenční standardy MeSH
- sorbitol MeSH
- stabilita léku MeSH
- tobolky MeSH
- vysokoúčinná kapalinová chromatografie metody MeSH
- želatina MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- ibuprofen MeSH
- polysorbáty MeSH
- sorbitol MeSH
- tobolky MeSH
- želatina MeSH
Unknown impurities were identified in ibuprofen (IBU) soft gelatin capsules (SGCs) during long-term stability testing by a UHPLC method with UV detection and its chemical formula was determined using high resolution/accurate mass (HRAM) LC-MS. Reference standards of the impurities were subsequently synthesized, isolated by semi-preparative HPLC and characterized using HRAM LC-MS, NMR and IR. Two impurities were formed by esterification of IBU with polyethylene glycol (PEG), which is used as a fill of the SGCs, and were identified as IBU-PEG monoester and IBU-PEG diester. Two other degradants arised from reaction of IBU with sorbitol and sorbitan, which are components of the shell and serves as plasticizers. Thus, IBU sorbitol monoester (IBU-sorbitol) and IBU sorbitan monoester (IBU-sorbitan ester) were identified. An UHPLC method was further optimized in order to separate, selectively detect and quantify the degradation products in IBU SGCs.
Saneca Pharmaceuticals Nitrianska 100 920 27 Hlohovec Slovak Republic
Zentiva A Sanofi Company U Kabelovny 130 102 37 Prague 10 Czech Republic
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