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Updated: May 9, 2026

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment

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A validated specific stability-indicating RP-HPLC assay method for Ambrisentan and its related substances.

M B V Narayana¹, K B Chandrasekhar², B M Rao³

¹Matrix Laboratories Private Limited, Hyderabad 500 078, India balajimachireddy@gmail.com.

Journal of Chromatographic Science

|August 9, 2013

Summary

A stability-indicating liquid chromatographic method was developed to quantify Ambrisentan and its impurities. The method demonstrated effectiveness in assessing drug quality during batch release and storage.

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Published on: April 23, 2019

Area of Science:

Analytical Chemistry
Pharmaceutical Analysis

Background:

Ambrisentan quality control requires methods that can distinguish the active pharmaceutical ingredient from impurities and degradation products.
Stability-indicating methods are crucial for assessing drug product shelf-life and ensuring patient safety.

Purpose of the Study:

To develop and validate a stability-indicating reverse-phase liquid chromatographic (LC) method for Ambrisentan.
To quantify Ambrisentan and its related substances in bulk and pharmaceutical dosage forms.
To assess the method's ability to detect degradation products under various stress conditions.

Main Methods:

Forced degradation studies (acid, base, oxidative, thermal, photolytic) were performed on Ambrisentan.
A reverse-phase LC method using a SunFire C18 column and a gradient elution was optimized.
Method validation was conducted according to International Council for Harmonisation (ICH) guidelines.

Main Results:

The LC method achieved good resolution between Ambrisentan, its impurities, and degradation products.
Significant degradation was observed under acidic and basic conditions; no degradation occurred under oxidative, thermal, or photolytic stress.
Mass balance ranged from 98.9% to 100.3%, confirming the method's stability-indicating nature.

Conclusions:

The developed stability-indicating LC method is suitable for quantitative determination of Ambrisentan and its related substances.
The method can be reliably used for quality control of Ambrisentan bulk samples at batch release and during stability studies.