Zobrazeno 1 - 10
of 21
pro vyhledávání: '"Petr Gibala"'
Publikováno v:
Journal of pharmaceutical and biomedical analysis. 218
The possibility of N-Nitrosation in the absence of nitrosating agents was studied on model solutions and film coated tablets containing metformin. N-nitrosodimethylamine (NDMA) and N-nitrosation precursors (dimethylamine and nitrites) were determined
Publikováno v:
Journal of pharmaceutical and biomedical analysis. 205
4'-(azidomethyl)-[1,1'-biphenyl]-2-carbonitrile (GTI-azide-1) and 5-(4'-(azidomethyl)-[1,1'-biphenyl]-2-yl)-1H-tetrazole (GTI-azide-2) are potentially genotoxic impurities that can be present at trace levels in the active pharmaceutical ingredients a
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 149:214-224
An HPLC method with UV and electrospray ionization - mass spectrometry (ESI-MS) detection was developed for the separation and determination of obeticholic acid (OBE) and its related compounds in development process and quality control. OBE and its r
Autor:
Pavel Řezanka, Petr Gibala, Jakub Rudovský, Stanislav Kalášek, Tomas Kubelka, Michal Douša, Jan Hrubý, Jakub Jireš
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 195:113877
An effective analytical method for the quantification of N-nitrosodimethylamine (NDMA) using a liquid chromatography coupled with tandem mass spectrometry was developed and applied to a process optimization study of the production of metformin film c
Publikováno v:
Journal of Separation Science. 39:851-856
The amino alcohols in l-valinol were effectively separated and quantified using hydrophilic interaction chromatography with fluorescence detection. The influence of the mobile phase (salt type, buffer concentration, and pH) on retention was studied.
Autor:
Josef Jirman, Luděk Meca, Jana Salandova, Marcela Tkadlecova, Michal Douša, Petr Gibala, Jiří Břicháč, Eva Kovalčíková, Jan Srbek
Publikováno v:
Journal of chromatographic science. 55(8)
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. Refere
Publikováno v:
Journal of Pharmaceutical Sciences. 101:1811-1820
The acid hydrolysis of various selected saccharide- and polysaccharide-based pharmaceutical excipients under acid hydrolysis and the formation of degradation compounds were studied. New degradation products formed from these excipients were discovere
Autor:
Petr Gibala, Michal Douša
Publikováno v:
Journal of Separation Science. 35:798-803
A sensitive, specific, and rapid high-performance liquid chromatography (HPLC) method for the determination of ambrisentan enantiomers has been developed and validated. Six chiral columns were tested in a reversed-phase system. Excellent enantiosepar
Autor:
Zuzana Mandelova, Michal Douša, Petr Gibala, Tomáš Pekárek, Jiří Břicháč, Stanislav Radl, Ondřej Klecán
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 58:1-6
A new impurity was detected and determined using gradient ion-pair UHPLC method with UV detection in zolmitriptan (ZOL). Using MS, NMR and IR study the impurity was identified as (4 S ,4′ S )-4,4′-(2,2′-(4-(dimethylamino)butane-1,1-diyl)bis(3-(