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Development of a novel chromatographic method for concurrent determination of 5-fluorouracil and cisplatin: Validation, greenness evaluation, and application on drug-eluting film

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dc.contributor.authorYoussef, S.H.
dc.contributor.authorAfinjuomo, F.
dc.contributor.authorSong, Y.
dc.contributor.authorGarg, S.
dc.date.issued2021
dc.descriptionData source: Supplementary data, https://doi.org/10.1016/j.microc.2021.106510
dc.description.abstractThe combination of 5-fluorouracil (5-FU) and cisplatin (Cis) has been used for the treatment of many cancers. The combination demonstrates synergy and improved clinical outcomes encouraging developing a formulation with both drugs. An analytical procedure is essential for formulation studies; however, no method has been reported for the concurrent determination and quantification of both 5-FU and Cis to date. A novel, simple, accurate, and precise HPLC method was developed using a C18 column (250 mm × 4.6 mm, 5 µm) and mobile phase composed of 0.5 mM sodium dodecyl sulfate: methanol (98:2, v/v), adjusted to pH 2.5 with phosphoric acid. A flow rate of 0.5 mL/min was applied and a photodiode array was utilized for detection and the retention times were 9.89 min (265 nm) for 5-FU and 5.36 min (210 nm) for Cis. Validation procedures were performed, and the method was found to be linear at ranges of 0.9–60.0 µg/mL for 5-FU and 6.0–60.0 µg/mL for Cis. The limits of detection (LOD) and quantitation (LOQ) were 0.10 and 0.25 µg/mL for 5-FU and 2.00 and 4.00 µg/mL for Cis, respectively. Other parameters such as precision, selectivity, robustness, and stability results were within acceptable limits. The method was applied to a model co-eluting film and its release profile was studied. Additionally, the method's greenness was evaluated by four assessment tools namely the national environmental method index (NEMI), analytical eco scale assessment (ESA), green analytical procedure index (GAPI), and Analytical GREEnness Metric Approach and Software (AGREE). The results demonstrated compliance with green analytical chemistry (GAC) practices. This research acts as a step towards further investigation of drug stability under different stress conditions and quantification of the intact drugs in presence of their degradation products.
dc.identifier.citationMicrochemical Journal, 2021; 168(106510)
dc.identifier.doi10.1016/j.microc.2021.106510
dc.identifier.issn0026-265X
dc.identifier.issn1095-9149
dc.identifier.orcidGarg, S. [0000-0001-7253-2629]
dc.identifier.urihttps://hdl.handle.net/11541.2/147729
dc.language.isoen
dc.publisherELSEVIER
dc.rightsCopyright 2021 Elsevier B V Access Condition Notes: Accepted manuscript available after 1 October 2023
dc.source.urihttps://doi.org/10.1016/j.microc.2021.106510
dc.subjectchromatographic method
dc.subjectgreen analytical method
dc.subjectcisplatin
dc.subject5-fluorouracil
dc.subjectdrug-eluting film
dc.titleDevelopment of a novel chromatographic method for concurrent determination of 5-fluorouracil and cisplatin: Validation, greenness evaluation, and application on drug-eluting film
dc.typeJournal article
pubs.publication-statusPublished
ror.fileinfo12248084230001831 13248084220001831 Open Access Postprint
ror.mmsid9916530208501831

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