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

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  • Vora Muskan Mahammad Usman
  • Kartik B. Vyas

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.

Suggested Citation

  • Vora Muskan Mahammad Usman & Kartik B. Vyas, 2026. "Development and Validation of a Stability-Indicating HPLC Method for the Quantitative Estimation of Resmetirom," International Journal of Scientific Research in Chemistry, International Journal of Scientific Research in Chemistry, vol. 11(2), pages 04-08, March.
    • Handle: RePEc:cuo:ijsrch:v11:y2026:i2:id:74
    DOI: 10.32628/IJSRCH261122
    Note: Article URL: https://ijsrch.com/home/article/view/IJSRCH261122
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