Micellar Liquid Chromatography Determination of Edoxaban in Oral Solid Dosage Forms: Theoretical Aspects and Validation.

ABSTRACT: A method based on micellar liquid chromatography has been developed to quantify edoxaban in oral solid dosage forms. Samples are dissolved in methanol and diluted in mobile phase up to nearly 5 mg L^-1 and directly injected. The drug is resolved in less than 8 min using a C18 column and an isocratic mobile phase of 0.10 M sodium dodecyl sulfate -4%, v/v 1-butanol buffered at pH = 3 with a phosphate salt, running at 1 mL min^{- 1}. The detection wavelength is 290 nm. The procedure is successfully validated by the guidelines of the International Conference on Harmonization. The calibration curve is linear (r² > 0.999) over the interval 1-10 mg L^-1. Trueness is 100.4-103.0% and precision < 1.7% and is finally applied to commercial tablets. Th

SUBMITTER: Peris-Vicente J 

PROVIDER: S-EPMC12640664 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature