Estimation of rezdiffra (MGL-3196) by validated RP-HPLC approach in bulk material and pharmaceutical formulation

Rezdiffra MGL-3196 is a newly authorized systemic medication for moderate to severe liver fibrosis associated with noncirrhotic nonalcoholic steatohepatitis (NASH).

The objective is to create a high-performance liquid chromatographic method for rezdiffra assessment that is simple, accurate, and validated in compliance with ICH guidelines.

Data processing was done using Chromeleon software and Vanquish HPLC. Rezdiffra was effectively separated using a mobile phase containing of 0.05% Trifluoroacetic acid in 80% of Acetonitrile at a wavelength of 220 nm and a flow rate of 1.0 ml/min on an ODS, C18; 4.6 mm × 250 cm; 5 µm, packed USP column. At 3.5 min, the rezdiffra replied. Selectivity, precision, linearity, LOD/LOQ, accuracy, robustness, and solution stability were among the validation metrics whose performance was confirmed.

There was no interference, and all the peaks were well separated. Over the range of 5-200 mcg/ml, the correlation coefficient of rezdiffra was 0.9996, indicating that the technique-maintained linearity at varying concentrations. The percentage of the rezdiffra recovered at various concentrations fell between 98.0 and 102.0. The absolute difference of the content at various adjusted circumstances was within 2.0 of the original condition when the column temperature and the flow rate were altered from the real rate. After 24 h at room temperature, autosampler (15 °C to 25 °C), and refrigerator (2-8 °C), the solutions remained stable.

The verified HPLC method can be a practical analytical technique for the analysis of Rezdiffra in pharmaceutical products.