RP-HPLC Method Development and Validation for Simultaneous Estimation of Bempedoic Acid and Ezetimibe in Pharmaceutical Dosage Forms

  • Unique Paper ID: 204764
  • Volume: 13
  • Issue: 1
  • PageNo: 4254-4257
  • Abstract:
  • Hypercholesterolemia is a major risk factor for cardiovascular diseases and is commonly managed using lipid-lowering agents such as Bempedoic Acid and Ezetimibe. The increasing use of fixed-dose combination products necessitates the development of reliable analytical methods for their quality control and routine analysis. The present study was aimed at developing and validating a simple, accurate, precise, and economical reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous estimation of Bempedoic Acid and Ezetimibe in pharmaceutical dosage forms. Chromatographic separation was achieved using a C18 column with a mobile phase consisting of phosphate buffer and acetonitrile under optimized conditions. Detection was performed at 240 nm. The developed method was validated according to ICH Q2(R1) guidelines for parameters including specificity, linearity, precision, accuracy, robustness, limit of detection, and limit of quantification. The results demonstrated excellent chromatographic performance with good peak symmetry, high resolution, and acceptable validation characteristics. The method was found to be suitable for routine quality control analysis of combined dosage forms containing Bempedoic Acid and Ezetimibe.

Copyright & License

Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

BibTeX

@article{204764,
        author = {P Anupama},
        title = {RP-HPLC Method Development and Validation for Simultaneous Estimation of Bempedoic Acid and Ezetimibe in Pharmaceutical Dosage Forms},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {4254-4257},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=204764},
        abstract = {Hypercholesterolemia is a major risk factor for cardiovascular diseases and is commonly managed using lipid-lowering agents such as Bempedoic Acid and Ezetimibe. The increasing use of fixed-dose combination products necessitates the development of reliable analytical methods for their quality control and routine analysis. The present study was aimed at developing and validating a simple, accurate, precise, and economical reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous estimation of Bempedoic Acid and Ezetimibe in pharmaceutical dosage forms. Chromatographic separation was achieved using a C18 column with a mobile phase consisting of phosphate buffer and acetonitrile under optimized conditions. Detection was performed at 240 nm. The developed method was validated according to ICH Q2(R1) guidelines for parameters including specificity, linearity, precision, accuracy, robustness, limit of detection, and limit of quantification. The results demonstrated excellent chromatographic performance with good peak symmetry, high resolution, and acceptable validation characteristics. The method was found to be suitable for routine quality control analysis of combined dosage forms containing Bempedoic Acid and Ezetimibe.},
        keywords = {Bempedoic Acid, Ezetimibe, RP-HPLC, Method Validation, ICH Guidelines, Pharmaceutical Analysis.},
        month = {June},
        }

Cite This Article

Anupama, P. (2026). RP-HPLC Method Development and Validation for Simultaneous Estimation of Bempedoic Acid and Ezetimibe in Pharmaceutical Dosage Forms. International Journal of Innovative Research in Technology (IJIRT), 13(1), 4254–4257.

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