Direct separation of the enantiomers of ramosetron on a chlorinated cellulose-based chiral stationary phase in hydrophilic interaction liquid chromatography mode.
Chiralpak IC-3
antiemetic drugs
enantiomer separation
hydrophilic interaction liquid chromatography
ramosetron
Journal
Journal of separation science
ISSN: 1615-9314
Titre abrégé: J Sep Sci
Pays: Germany
ID NLM: 101088554
Informations de publication
Date de publication:
Jul 2020
Jul 2020
Historique:
received:
11
03
2020
revised:
07
04
2020
accepted:
07
04
2020
pubmed:
17
4
2020
medline:
1
4
2021
entrez:
17
4
2020
Statut:
ppublish
Résumé
Ramosetron is an enantiopure active pharmaceutical ingredient marketed in Japan since 1996 and later in a few Southeast Asian countries predominantly as an antiemetic for patients receiving chemotherapy. In this study, a simple and rapid high-performance liquid chromoatography method for the separation of ramosetron and its related enantiomeric impurity by using hydrophilic interaction liquid chromatography mode is presented. Chiral resolution was performed on an analytical column (100 mm × 4.6 mm id) packed with 3 μm particles of cellulose-based Chiralpak IC-3 chiral stationary phase. Using a mobile phase containing acetonitrile-water-diethylamine (100:10:0.1, v/v/v) and setting the column temperature at 35°C, the resolution value was 7.35. At a flow rate of 1 mL/min, the enantioseparation was completed within 5 min. The proposed method was partially validated and it has proven to be sensitive with limit of detection and limit of quantitation of the (S)-enantiomer impurity of 44.5 and 133.6 ng/mL.
Identifiants
pubmed: 32297397
doi: 10.1002/jssc.202000290
doi:
Substances chimiques
Acetonitriles
0
Benzimidazoles
0
Diethylamines
0
Water
059QF0KO0R
ramosetron
7ZRO0SC54Y
Cellulose
9004-34-6
diethylamine
B035PIS86W
acetonitrile
Z072SB282N
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2589-2593Informations de copyright
© 2020 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
Références
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