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

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, R² = 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.