Micellar liquid chromatography as a sustainable tool to quantify three statins in oral solid dosage forms
•A method to determine three statins in oral dosage forms been developed.•It was based on direct injection – micellar liquid chromatography.•The procedure was validated by the guidelines of ICH.•It was sustainable, rapid, inexpensive and with high sample throughput.•The influence of the composition...
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Veröffentlicht in: | Journal of Chromatography A 2023-06, Vol.1698, p.464000, Article 464000 |
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Sprache: | eng |
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Zusammenfassung: | •A method to determine three statins in oral dosage forms been developed.•It was based on direct injection – micellar liquid chromatography.•The procedure was validated by the guidelines of ICH.•It was sustainable, rapid, inexpensive and with high sample throughput.•The influence of the composition of the mobile phase on retention factor was established.
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 ( |
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ISSN: | 0021-9673 1873-3778 |
DOI: | 10.1016/j.chroma.2023.464000 |