Stability-Indicating HPLC Assay for Determination of Idebenone in Pharmaceutical Forms

Abstract

A stability-indicating method was validated for the determination in pharmaceutical forms of idebenone a coenzyme Q10-like compound. The assay was achieved by liquid chromatography analysis using a reversed-phase C18 column and a detector set at 480 nm. The optimized mobile phase consisted of isocratic flow rate at 1.0 mL/min for 3 min with methanol. The linearity of the assay was demonstrated in the range of 3.0 to 8.0 mg/mL with a correlation coefficient r 2 > 0.998. The limits of detection and quantification were 0.03 and 0.05 mg/mL, respectively. The intraday and interday precisions were less than 1.0%. Accuracy of the method ranged from 98.6 to 101.5% with RSD < 0.6%. Specificity of the assay showed no interference from tablets components and breakdown products formed by alkaline, acidic, oxidative, sunlight, and high temperature conditions. This method allows accurate and reliable determination of idebenone for drug stability assay in pharmaceutical studies.

Analytical Method and Stability Study for Oral Suspension of Idebenone in Syrspend

“…Stability studies are essential to know the effect of storage conditions of a galenic product to determine the appropriate shelf life and storage conditions [14]. The IDB works as a CoQ10-like compound exhibiting similar antioxidant and electron chain transport (ETC) properties involved in the generation of ATP [4]. IDB acts by transferring electrons directly to complex III of the ETC chain, bypassing the cofactor chain of complex I, restoring the generation of cellular energy (ATP) [5].…”

“…The International Conference on Harmonization (ICH) [15] suggests that analytical test procedures for stability samples should be fully validated [16]. There are reported methods for the determination of ubiquinones by HPLC-UV-vis [4,17,18], colorimetric methods [19], HPTLC [16], and, finally, GC-MS or LC-MS [3,16,20]. LC-MS appears to be the gold standard for sta-bility studies of pharmaceutical preparations thanks to the ability to quantify analytes in solution, and to the high sensitivity and reproducibility inherent of MS. A fully validated HPLC-MS/MS method has been applied but for pharmacokinetic study [3] in plasma and urine samples to detect IDB and metabolites as reported above.…”