ABSTRACT

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). In this reaction,the carboxylic group reacts with MBTH to form a hydrazone derivative. This derivative is then oxidized by Ferric chloride to form a green to bluish color complex, which can be measured spectrophotometrically. At 663 nm, the coloured 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 fall 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. The proposed technique outcomes were found to be in strong agreement with those of the reference approach. The technique was discovered to be simple, precise, accurate, and sensitive; it may be utilised for regular analysis of Bempedoic acid in dosage forms such as tablets and bulk. Keywords: Bempedoic acid, Visible spectrophotometry, MBTH (3-methyl-2-benzothiazolinone Hydrazone), Validation, Tablet dosage forms
Publication date: 01/12/2024

https://ijbpas.com/pdf/2024/December/MS_IJBPAS_2024_8508.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.12.8508