Application of chemometric approach for development and validation of high performance liquid chromatography method for estimation of ropinirole hydrochloride.
forced degradation
liquid chromatography
method validation
quality by design
robustness
Journal
Journal of separation science
ISSN: 1615-9314
Titre abrégé: J Sep Sci
Pays: Germany
ID NLM: 101088554
Informations de publication
Date de publication:
Nov 2019
Nov 2019
Historique:
received:
07
05
2019
revised:
22
08
2019
accepted:
23
08
2019
pubmed:
30
8
2019
medline:
14
4
2020
entrez:
30
8
2019
Statut:
ppublish
Résumé
A systematic Quality by Design approach was employed for developing an isocratic reversed-phase liquid chromatographic technique for the estimation of ropinirole hydrochloride in bulk drug and pharmaceutical formulations. LiChrospher RP 18-5 Endcapped column (25 cm × 4.6 mm id) at ambient temperature (25 ± 2°C) was used for the chromatographic separation of the drug. The screening of factors influencing chromatographic separation of the active pharmaceutical ingredient was performed employing fractional factorial design to identify the influential factors. Optimization of the selected factors was carried out using central composite design for selecting the optimum chomatographic conditions. The mobile phase employed was constituted of Solvent A/Solvent B (65:35 v/v) (Solvent A [methanol/0.05 M ammonium acetate buffer, pH 7, 80:20 v/v] and Solvent B [high performance liquid chromatography grade water]) and used at 0.6 mL/min flow rate, while UV detection was performed at 250 nm. Linearity was achieved in the drug concentration range 5-100 µg/mL (R
Identifiants
pubmed: 31465611
doi: 10.1002/jssc.201900458
doi:
Substances chimiques
Indoles
0
ropinirole
030PYR8953
Types de publication
Journal Article
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
3293-3301Informations de copyright
© 2019 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
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