Development and Validation of a Stability-Indicating HPLC Method for the Quantitative Estimation of Resmetirom

Vora Muskan Mahammad Usman and Kartik B. Vyas

International Journal of Scientific Research in Chemistry, 2026, vol. 11, issue 2, 04-08

Abstract: The present paper describes the development and validation of a simple, precise, and stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the quantitative estimation of Resmetirom in bulk and pharmaceutical formulations. Chromatographic separation was achieved using a C18 column with a mobile phase consisting of acetonitrile and phosphate buffer in an optimized ratio under isocratic conditions. The flow rate, detection wavelength, and injection volume were systematically optimized to provide sharp, symmetrical peaks with adequate resolution. Resmetirom exhibited a retention time that ensured effective separation from degradation products and excipients. The method was validated in accordance with ICH Q2(R1) guidelines for specificity, linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ). Linearity was observed over a suitable concentration range with a correlation coefficient (R²) greater than 0.999, demonstrating excellent proportionality between peak area and analyte concentration.

Keywords: Resmetirom; Sensitivity; Selectivity; Reverse phase HPLC and Validation (search for similar items in EconPapers)
Date: 2026
Note: Article URL: https://ijsrch.com/home/article/view/IJSRCH261122
References: Add references at CitEc
Citations:

Downloads: (external link)
https://ijsrch.com/home/article/view/IJSRCH261122 Article URL (text/html)
https://ijsrch.com/home/article/download/IJSRCH261122/IJSRCH261122 Full text (application/pdf)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:cuo:ijsrch:v11:y2026:i2:id:74

DOI: 10.32628/IJSRCH261122

Access Statistics for this article

More articles in International Journal of Scientific Research in Chemistry from International Journal of Scientific Research in Chemistry
Bibliographic data for series maintained by Pankaj Sharma ().