• Archana S. Gurjar
• Shrikant S. Thalkari

Bempedoic acid is a novel oral inhibitor of adenosine triphosphate (ATP)-citrate lyase, often prescribed in statin intolerant patients for additional lowering of bad cholesterol. Literature revealed methods focused mainly on simultaneous estimation of bioanalytical samples with the use of strong reagents in the mobile phase such as o-phosphoric acid and triethylamine, which may lead to issues in the long run. In this research article, reversed phase isocratic HPLC method has been developed and validated for the determination of bempedoic acid in bulk and solid pharmaceutical dosage form. Hemochrom C18 (150mm × 4.6mm ID, particle size 5μ) column has been used for the RP-HPLC. The optimized mobile phase consists of 0.05% Formic acid: Acetonitrile (43:57v/v). Isocratic flow was set at 1 mL/min and run time was 15min respectively. Detection has been performed at 212 nm, room temperature with good elution for injection volume of 50μL. The separation of bempedoic acid occurred at retention time of 5.060min. %RSD of the bempedoic acid was found to be 0.20. %Recovery of bempedoic acid was obtained as 99.99%. LOD, LOQ values derived from regression equation of bempedoic acid were 5.9318ppm (µg/mL) and 17.9753ppm (µg/mL), respectively. Regression equation of bempedoic acid was y=1476.8 x+3024.8 and the calibration curve indicates that the correlation coefficient (R2) was excellent with a value of 0.9997. Thus, this developed method is unique, very simple and economical which can be adopted in regular Quality Control test in industries for an API as well as bulk dosage form.

Bempedoic Acid, RP-HPLC, Method Validation, Dosage form.

"A SIMPLE, RAPID AND VALIDATED RP-HPLC METHOD FOR THE ESTIMATION OF BEMPEDOIC ACID IN BULK ACTIVE PHARMACEUTICAL INGREDIENT AND TABLET DOSAGE FORM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 11, page no.f1-f8, November-2024, Available :http://www.jetir.org/papers/JETIR2411501.pdf

"A SIMPLE, RAPID AND VALIDATED RP-HPLC METHOD FOR THE ESTIMATION OF BEMPEDOIC ACID IN BULK ACTIVE PHARMACEUTICAL INGREDIENT AND TABLET DOSAGE FORM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 11, page no. ppf1-f8, November-2024, Available at : http://www.jetir.org/papers/JETIR2411501.pdf