New Micellar Electrokinetic Chromatographic Method for Analyzing Idebenone in Pediatric Formulations

CONTIN M., ; BUONTEMPO F; GARCIA BECERRA C.; DOBRECKY C.,; LUCANGIOLI S.; TRIPODI V.

JOURNAL OF CHROMATOGRAPHIC SCIENCE

PRESTON PUBL INC

Lugar: Niles; Año: 2017 vol. 55 p. 351 - 357

0021-9665

A novel, simple and reliable method based on micellar electrokinetic chromatography with ultraviolet detection was developed to analyze idebenone in a pediatric formulation. Idebenone is a synthetic short chain benzoquinone that acts as an electron carrier in the mitochondrial electrontransport chain facilitating the production of adenosine triphosphate. It can be found in two different redox states that differ in their physiological properties. Idebenone has been investigated as atreatment in several neurological disorders like Friedreich?s ataxia, Leber?s hereditary optic neuropathy, mitochondrial encephalomyopathies and senile dementia. Accordingly, a micellar electrokinetic chromatography was employed to discriminate both redox forms. The final optimizedsystem was validated in terms of selectivity, linearity (r2 0.992), limit of detection (0.5 µg/mL), limitof quantification (1.8 µg/mL), intra- and inter-day precision (RSD ≤ 2) and accuracy in terms ofrecovery studies (99.3?100.5%). Robustness was studied following a Plackett?Burman design.Finally, the validated system was applied to the analysis of idebenone in a pediatric formulation.