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

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. The method is found to be quite sustainable by several quantitative assessed tools. The surfactant is found to be the primary contributor to the elution strength of the mobile phase and the partition constants of the equilibria involved in retention are determined. The method uses a low quantity of hazardous chemicals; is easy to conduct, safe, eco-friendly, and cost-effective, and offers a high sample throughput, thus suitable for routine analysis.