Stability-indicating RP-HPLC method development and validation for determination of nine impurities in apixaban tablet dosage forms. Robustness study by quality by design approach.
RP-HPLC
apixaban
impurities
method development
quality by design
validation
Journal
Biomedical chromatography : BMC
ISSN: 1099-0801
Titre abrégé: Biomed Chromatogr
Pays: England
ID NLM: 8610241
Informations de publication
Date de publication:
Jan 2020
Jan 2020
Historique:
received:
01
08
2019
revised:
30
08
2019
accepted:
01
10
2019
pubmed:
22
10
2019
medline:
23
1
2020
entrez:
22
10
2019
Statut:
ppublish
Résumé
A quality by design (QbD) based high-resolution HPLC method is described for determination of impurities in apixaban (APX) in the tablet dosage form. Employing a simple and stability-indicating HPLC method, nine known impurities were quantified with good peak resolution. Mobile phase A (MP-A) was prepared with buffer and acetonitrile 90:10 v/v, while mobile phase B (MP-B) contained water and acetonitrile 10:90 v/v. The gradient program was 0 min, MP-A 75%, B 25%; 20 min, MP-A 65%, B 35%; 30 min, MP-A 40%, B 60%; 40min, MP-A 40%, B 60%; 42 min, MP-A 75%, B 25%; and 50 min, MP-A 75%, B 25%. The chromatographic separation was achieved using a Zorbax RX C
Substances chimiques
Pyrazoles
0
Pyridones
0
Tablets
0
apixaban
3Z9Y7UWC1J
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e4719Informations de copyright
© 2019 John Wiley & Sons, Ltd.
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