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Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...

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An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules

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

Md Abid Hasan^1,2, Raisa Tasnim Simran², Ejaj Sumit^1,3

¹Department of Pharmacy, University of Asia Pacific, Dhaka, Bangladesh.

Drug Development and Industrial Pharmacy

|April 7, 2026

Summary

A new HPLC method accurately measures Rezdiffra, a medication for liver fibrosis in NASH patients. This validated technique ensures reliable Rezdiffra analysis in pharmaceutical products.

Keywords:

Analytical Method MGL-3169 RP-HPLC Rezdiffra validation

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Area of Science:

Analytical Chemistry
Pharmacology

Background:

Rezdiffra (Resmetirom) is a new systemic medication for moderate to severe liver fibrosis in noncirrhotic nonalcoholic steatohepatitis (NASH).
Accurate quantification of Rezdiffra is crucial for its therapeutic application.

Purpose of the Study:

To develop and validate a high-performance liquid chromatographic (HPLC) method for Rezdiffra assessment.
Ensure the method is simple, accurate, and compliant with ICH guidelines.

Main Methods:

Utilized Vanquish HPLC with Chromeleon software for data processing.
Employed a specific mobile phase (0.05% Trifluoroacetic acid in 80% Acetonitrile) and an ODS, C18 column.
Validated the method for selectivity, precision, linearity, LOD/LOQ, accuracy, robustness, and solution stability.

Main Results:

Achieved excellent separation of Rezdiffra peaks with no interference.
Demonstrated linearity with a correlation coefficient of 0.9996 over the 5-200 mcg/ml range.
Confirmed method accuracy (98.0-102.0% recovery) and stability under various conditions.

Conclusions:

The validated HPLC method is suitable for practical and reliable analysis of Rezdiffra in pharmaceutical formulations.
This method supports quality control and therapeutic monitoring of Rezdiffra.