A Bioanalytical Method for Eliglustat Quantification in Rat Plasma.

A simple and sensitive bioanalytical HPLC-UV method has been developed and validated for quantification of eliglustat in rat plasma. The liquid-liquid extraction method was found to be more efficient compared to protein precipitation technique. Chromatographic separation of eliglustat was achieved using Kromasil C18 column with a mobile phase consisting of a mixture of methanol and ammonium acetate (pH 3.2) in a ratio of 60:40. Detection wavelength was set at 282 nm. The developed method was specific, accurate, precise with good recovery and stability profile. The calibration curve constructed over a range of 0.3-10 μg/mL was linear (R2 > 0.997). Accuracy in intra and inter-day assay were found to be 96.27-107.35% and 96.80-106.57%, respectively. The corresponding precision (%CV) values were within 4.31-10.90% and 4.82-9.97%, respectively. Till date, no method is available for bioanalysis of eliglustat in any type of biological matrix. This is the first time to report a bioanalytical method for this molecule. The developed bioanalytical method was applied to quantitate eliglustat in the plasma samples of a single dose oral pharmacokinetic study in Sprague Dawley rat.