A quality-by-design evaluated liquid chromatography method development and validation for the separation and quantification of nitroxoline and its impurities.
design of experiments
development
nitroxoline
quality by design
validation
Journal
Journal of separation science
ISSN: 1615-9314
Titre abrégé: J Sep Sci
Pays: Germany
ID NLM: 101088554
Informations de publication
Date de publication:
22 Dec 2023
22 Dec 2023
Historique:
revised:
29
11
2023
received:
13
10
2023
accepted:
03
12
2023
medline:
23
12
2023
pubmed:
23
12
2023
entrez:
22
12
2023
Statut:
aheadofprint
Résumé
A novel, isocratic, sensitive, stability-indicating high-performance liquid chromatography method was developed for the separation and quantification of related substances in nitroxoline (NTL). The chromatographic separation has been achieved on Inertsil ODS-3 V, (250 × 4.6 mm, 5 μm) at 240 nm using ethylenediamine tetraacetic acid buffer and methanol in the ratio of 60:40 v/v as mobile phase. The performance of the method has been checked as per the International Conference on Harmonization guidelines for specificity, linearity, accuracy, precision, and robustness. Regression analysis showed a correlation coefficient value greater than 0.99 for NTL and its three impurities. The detection limit of impurities was in the range of 0.01% (0.05 μg/mL)-0.22% (1.1 μg/mL) indicating the sensitivity of the newly developed method. The accuracy of the method was established based on the recovery obtained between 94.7% and 104.1% for all the impurities. The percentage relative standard deviation obtained for the repeatability was less than 4.0% at the specification level for all impurities. Forced degradation was performed to establish the stability-indicating nature of the method and to know about the degradation products, the quality of a drug substance changes with time under the influence of stress conditions. Thus, the proposed method was validated and found to be specific, sensitive, linear, accurate, precise, reproducible, and beneficial for routine usage.
Identifiants
pubmed: 38135885
doi: 10.1002/jssc.202300760
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e2300760Informations de copyright
© 2023 Wiley-VCH GmbH.
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