Stability Indicating Method Development and Validation for the Estimation of Bempedoic Acid by RP-HPLC

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences

Background:

• Bempedoic acid (BEM) is an orally administered prodrug.
• It functions as an Adenosine triphosphate-citrate Lyase (ACL) inhibitor.
• BEM is prescribed for atherosclerotic cardiovascular diseases and hypercholesterolemia.

Purpose of the Study:

• To develop and validate a stability-indicating HPLC method for BEM.
• To assess the drug's stability under various stress conditions.
• To confirm the chemical structures of BEM degradation products.

Main Methods:

• High-Performance Liquid Chromatography (HPLC) using a Kromasil 100-5-C8 column.
• UV detection at 234 nm with a mobile phase of acetonitrile and 0.1% Orthophosphoric Acid (OPA) buffer (70:30 v/v).
• Method validation according to ICH guidelines, including forced degradation studies.

Main Results:

• The method achieved a retention time of 1.88 minutes for BEM at ambient temperature.
• Excellent linearity, recovery (100.0%), and reproducibility (% RSD of 0.6) were demonstrated.
• The assay proved stability-indicating, successfully identifying degradation products under acidic, basic, peroxide, UV, heat, and humidity stress.

Conclusions:

• The validated HPLC method is suitable for confirming the chemical structures of bempedoic acid degradation products.
• The method adheres to ICH Q2 (R1) guidelines.
• This analytical approach supports the quality control of bempedoic acid formulations.