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Micellar liquid chromatography as a sustainable tool to quantify three statins in oral solid dosage forms

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Micellar liquid chromatography as a sustainable tool to quantify three statins in oral solid dosage forms

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dc.contributor.author García López, Lidia
dc.contributor.author Peris Vicente, Juan
dc.contributor.author Carda Broch, Samuel
dc.date.accessioned 2023-11-27T14:18:48Z
dc.date.available 2023-11-27T14:18:48Z
dc.date.issued 2023
dc.identifier.uri https://hdl.handle.net/10550/91458
dc.description.abstract A method based on micellar liquid chromatography has been developed to determine rosuvastatin, lovastatin and simvastatin in oral solid dosage forms. Samples were solved in mobile phase up to the target concentration, filtered and directly injected. The three statins were resolved in 30 min, using an aqueous solution of 0.10 M sodium dodecyl sulphate - 7.0% 1-butanol, buffered at pH 3 with 0.01 M phosphate salt as mobile phase, running under isocratic mode at 1 mL/min through a C18 column. Detection was at 240 nm. The effect of sodium dodecyl sulfate on elution strength was more important than that of the organic solvent. The procedure was successfully validated by the guidelines of the International Council for Harmonization in terms of: specificity, linearity (r2 > 0.990), calibration range (1.5 - 15 mg/L for rosuvastatin, 0.5-10 mg/L for lovastatin and simvastatin), limit of detection (0.4, 0.2 and 0.15 mg/L for rosuvastatin, lovastatin and simvastatin, respectively), trueness (98.8-101.7%), precision (<2.7%), carry-over effect, robustness, and stability. Values were inside the acceptance criteria of the Methods, Method Verification and Validation, Food and Drug Administration-Office of Regulatory Affairs, thus ensuring the reliability of the results. The main feature was the low proportion of organic solvent used, thus making the procedure sustainable and green. Besides, it was easy-to-conduct and with high sample-throughput, and then useful for routine analysis in pharmaceutical quality control. Finally, it was applied to commercial pharmaceutical preparations.
dc.language.iso eng
dc.relation.ispartof Journal of Chromatography A, 2023, vol. 1968, p. 464000
dc.source García López, Lidia, Peris Vicente, Juan, Carda Broch, Samuel (202). Micellar liquid chromatography as a sustainable tool to quantify three statins in oral solid dosage forms. Journal of Chromatography A, 1968, 464000. https://doi.org/10.1016/j.chroma.2023.464000
dc.subject química analítica
dc.subject lovastatin
dc.subject pharmaceutical
dc.subject rosuvastatin
dc.subject simvastatin
dc.subject validation
dc.title Micellar liquid chromatography as a sustainable tool to quantify three statins in oral solid dosage forms
dc.type journal article
dc.date.updated 2023-11-27T14:18:48Z
dc.identifier.doi 10.1016/j.chroma.2023.464000
dc.identifier.idgrec 157689
dc.rights.accessRights open access

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