A validated stability-indicating reversed-phase-HPLC method for dipyridamole in the presence of degradation products and its process-related impurities in pharmaceutical dosage forms.
HPLC
dipyridamole
impurities
stability indicating
validation
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:
05
09
2021
received:
29
04
2021
accepted:
10
09
2021
pubmed:
21
9
2021
medline:
27
1
2022
entrez:
20
9
2021
Statut:
ppublish
Résumé
In this study, we developed and validated a method to determine dipyridamole-related impurities in pharmaceutical dosage forms using the reversed-phase-HPLC technique. All impurities were separated on a YMC pack C8 (150 mm × 4.6 mm, 3.0 μm) analytical column using a suitable mobile phase. Mobile phase A was 10 mM concentration of phosphate buffer (pH adjusted to 4.7 by adding diluted orthophosphoric acid) and mobile phase B was buffer:acetonitrile:methanol (at the ratio of 30:40:30 v/v). The optimized chromatographic conditions used in the experiment were as follows: flow rate, 1.0 mL/min; injection volume, 10 μL and column temperature, 35°C. Chromatographic detection was performed at 295 nm. The stressed samples were analyzed for degradation under acidic, basic, peroxide, water hydrolysis, and physical degradation conditions. The proposed method was validated according to International Conference on Harmonization (ICH) guidelines, and found to be specific, linear, accurate and have a robust stability-indicating nature. The method showed excellent linearity from limit of quantification (LOQ) to 150% level of concentrations for all impurities. The correlation coefficient (r
Substances chimiques
Pharmaceutical Preparations
0
Dipyridamole
64ALC7F90C
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e5247Subventions
Organisme : GITAM Deemed
Informations de copyright
© 2021 John Wiley & Sons, Ltd.
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