DEVELOPMENT AND VALIDATION OF NOVEL RP-HPLC METHOD FOR THESIMULTANEOUS ESTIMATION OF EZETIMIBE AND BEMPEDOIC ACID IN A TABLETDOSAGE FORMAbstract
A simple, novel, precise, and cost-effective reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated to simultaneously estimate ezetimibe and bempedoic acid in the marketed tablet dosage form. The chromatographic separation was carried out on a Prontosil C18 (250 x 4.6 mm, 5 µm) column using a mobile phase of Acetonitrile: water (60:40 v/v). The flow rate was 1.0 mL/min with detection at 225 nm using UV detector. The retention time for bempedoic acid was 4.7 min, and for ezetimibe 5.7 min. Ezetimibe showed a linear response in the concentration range of 20-60 µg/mL. Bempedoic acid showed a linear response in 180-540 µg/mL concentration range. The correlation coefficient (‘r²’ value) for ezetimibe and bempedoic acid was 0.9982 and 0.9998, respectively. The results of analysis have been validated as per different validation parameters. The percentage recoveries obtained for ezetimibe and bempedoic acid range from 98%-102%.
Vandana Jain *, Daksha Rahamatkar and Shubham Nikam
Department of Quality Assurance, Oriental College of Pharmacy, Sanpada, Navi Mumbai, Maharashtra, India.
31 March 2022
25 April 2022
27 April 2022
01 November 2022