New Method Development and Validation of Bempedoic Acid

Bys: Karanam, Sridevi Ranjitha, Yarguntla, Srinivasa Rao, Kollabatthula, Vara Prasada Rao

A Visible Spectrophotometric method has been developed and validated for the quantitative measurement of Bempedoic acid in bulk and tablet dosage forms. The process is based on the production of a colored complex in the presence of Ferric chloride between Bempedoic acid and MBTH (3-methyl-2-benzothiazolinone Hydrazone). At 663 nm, the colored complex was spectrophotometrically measured. The correlation coefficient (r2) of 0.999 revealed that the approach is linear in the concentration range of 10-60 g/mL. It was discovered that the limits of detection (LOD) and quantitation (LOQ) were 2.169 g/mL and 6.572 g/mL, respectively. For both intra-day and inter-day precision studies, the approach was proven to be precise with a percent relative standard deviation (%RSD) less than 2.0%. Recovery experiments were used to assess the method's accuracy, and it was discovered that the average percentage of recovery fell between 98.0 and 102.0%. The results of the suggested approach were compared to those of the reference method for the accurate determination of Bempedoic acid in tablet dosage forms.

• Format: Paperback
• Language: English
• ISBN: 6208223563
• ISBN13: 9786208223564
• Release Date: October 2024
• Publisher: LAP Lambert Academic Publishing
• Length: 76 Pages
• Weight: 0.27 lbs.
• Dimensions: 0.2" x 6.0" x 9.0"