A Bioanalytical Method for Eliglustat Quantification in Rat Plasma.

Area of Science:

• Analytical Chemistry
• Pharmacokinetics
• Biotechnology

Background:

• Eliglustat is a crucial therapeutic agent requiring precise quantification in biological samples.
• Existing bioanalytical methods for eliglustat are lacking, hindering pharmacokinetic research.
• Accurate measurement of eliglustat is essential for understanding its absorption, distribution, metabolism, and excretion (ADME) profile.

Purpose of the Study:

• To develop and validate a sensitive and specific bioanalytical High-Performance Liquid Chromatography with Ultraviolet detection (HPLC-UV) method for quantifying eliglustat in rat plasma.
• To establish a reliable method for eliglustat analysis in biological matrices, addressing a gap in current research.
• To apply the validated method in a pharmacokinetic study to assess eliglustat's behavior in vivo.

Main Methods:

• Liquid-liquid extraction (LLE) was optimized for efficient isolation of eliglustat from rat plasma.
• Chromatographic separation was performed using a Kromasil C18 column with a methanol and ammonium acetate mobile phase (60:40, pH 3.2).
• Detection was set at 282 nm, and the method was validated for specificity, accuracy, precision, linearity, recovery, and stability.

Main Results:

• The developed HPLC-UV method demonstrated high sensitivity and specificity for eliglustat quantification.
• Linearity was confirmed over the concentration range of 0.3-10 μg/mL (R² > 0.997).
• The method exhibited excellent accuracy (96.27-107.35%) and precision (%CV within 10.90%), with good recovery and stability.

Conclusions:

• This study reports the first validated bioanalytical HPLC-UV method for eliglustat in rat plasma.
• The developed method is suitable for accurate and reliable quantification of eliglustat in pharmacokinetic studies.
• The method's successful application in a pharmacokinetic study validates its utility for in vivo drug analysis.