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Data Validation01:15

Data Validation

160
Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
160

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

Mansi V Chaudhari1, Ujwal Chaudhari1, Jagdish K Sahu1,2

  • 1Department of Pharmaceutical Quality Assurance, School of Pharmacy & Technology Management, SVKM's NMIMS (Deemed to be University), Shirpur, Distt - Dhule, Maharashtra, 425405, India.

Drug Metabolism and Bioanalysis Letters
|July 12, 2024
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Summary
This summary is machine-generated.

A validated HPLC method accurately quantifies bempedoic acid (BEM), an ACL inhibitor for hypercholesterolemia. This stability-indicating assay ensures drug quality and identifies degradation products under various stress conditions.

Keywords:
Bempedoic acidICH guidelinesRP-HPLCforced degradation.hypercholesterolemiaorthophosphoric acid

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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.