Stability-indicating reversed-phase-HPLC method development and validation for sacubitril/valsartan complex in the presence of impurities and degradation products: Robustness by quality-by-design approach.
design of experiments
impurities
reversed-phase-HPLC
sacubitril
valsartan
Journal
Biomedical chromatography : BMC
ISSN: 1099-0801
Titre abrégé: Biomed Chromatogr
Pays: England
ID NLM: 8610241
Informations de publication
Date de publication:
Jan 2022
Jan 2022
Historique:
revised:
01
09
2021
received:
11
05
2021
accepted:
01
09
2021
pubmed:
7
9
2021
medline:
27
1
2022
entrez:
6
9
2021
Statut:
ppublish
Résumé
According to current regulatory guidelines, a stability-indicating method has been developed to determine the impurities in sacubitril (SCB) and valsartan (VLS) tablet dosage forms and perform robustness studies using the design of experiments approach. The present study was initiated to understand quality target product profile, analytical target profile, and risk assessment for method variables that affect the method response. A reversed-phase-HPLC system was equipped with a Phenomenex Gemini-NX C
Substances chimiques
Aminobutyrates
0
Biphenyl Compounds
0
Drug Combinations
0
Valsartan
80M03YXJ7I
sacubitril and valsartan sodium hydrate drug combination
WB8FT61183
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e5240Informations de copyright
© 2021 John Wiley & Sons, Ltd.
Références
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