Sustainable HPLC Method for Resmetirom, a Novel THR-β Agonist: Development, Validation and Greenness Assessment (original) (raw)

Abstract

Resmetirom (RMT), a new drug approved for the treatment of metabolic dysfunction-associated steatohepatitis and the present work describes the development and validation of a reversed-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of RMT. The technique utilizes a Kromasil C18 column with mobile phase Acetonitrile and Ammonium acetate buffer (pH 3.5) in a 70:30 ratio, flow rate 0.8 mL min−1, and UV detection at 298 nm. The process was validated as per the ICH Q2 (R2) guidelines, exhibiting specificity, linearity (5–30 µg mL−1, _R_2 = 0.9951), precision (RSD < 2%), accuracy (98–102% recovery), LOD of 0.214 µg mL−1, and LOQ of 0.651 µg mL−1. The method is applicable to the active pharmaceutical ingredient (API) and was successfully validated to estimate RMT content present in tablets prepared in-house. The proposed analytical method was evaluated for environmentally friendliness, assessed qualitatively and quantitatively using AGREE, cGAPI, AGREEPrep, and MoGAPI software. The validated RP-HPLC method gives a good and efficient means for quantifying RMT, is cost saving and time efficient thereby applicable in pharmaceutical quality control and analysis.

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Acknowledgements

The authors thank the Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKMs, NMIMS, Mumbai, for providing experimental facilities.

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The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

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Authors and Affiliations

  1. Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM’s, NMIMS, Deemed to Be University, Vile Parle West, Mumbai, Maharashtra, 400056, India
    Khushi Dahiya & Sanjay Sharma

Authors

  1. Khushi Dahiya
  2. Sanjay Sharma

Contributions

Khushi Dahiya: Writing—original draft, Validation, Formal analysis. Sanjay Sharma: Conceptualization, Supervision, Writing—review & editing.

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Correspondence toSanjay Sharma.

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Dahiya, K., Sharma, S. Sustainable HPLC Method for Resmetirom, a Novel THR-β Agonist: Development, Validation and Greenness Assessment.Chromatographia 88, 717–725 (2025). https://doi.org/10.1007/s10337-025-04429-0

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