Micellar liquid chromatography as a sustainable tool to quantify three statins in oral solid dosage forms
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Título
Micellar liquid chromatography as a sustainable tool to quantify three statins in oral solid dosage formsAutoría
Fecha de publicación
2023-04-20Editor
ElsevierISSN
0021-9673; 1873-3778Cita bibliográfica
García-López, L., Peris-Vicente, J., Bose, D., Durgbanshi, A., & Carda-Broch, S. (2023). Micellar liquid chromatography as a sustainable tool to quantify three statins in oral solid dosage forms. Journal of Chromatography A, 1698, 464000.Tipo de documento
info:eu-repo/semantics/articleVersión
info:eu-repo/semantics/publishedVersionPalabras clave / Materias
Resumen
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, ... [+]
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 sulfate – 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. [-]
Publicado en
Journal of Chromatography A Volume 1698, 7 June 2023, 464000Datos relacionados
Data will be made available on request.Entidad financiadora
Ministerio de Ciencia, Innovación y Universidades | Department of Science and Technology, Ministry of Science and Technology, Government of India | Universitat de València
Código del proyecto o subvención
PID2019-106708GB-I00 | AEI/10.13039/501100011033 | Sl.No.64 Dated 31-05-2016
Derechos de acceso
© 2023 The Author(s). Published by Elsevier B.V.
info:eu-repo/semantics/openAccess
info:eu-repo/semantics/openAccess
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