Stability-Indicating RP-HPLC Method Development and Validation for Estimation of Remdesivir in Bulk and Pharmaceutical Formulations: A Comprehensive Review

The development of a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for remdesivir has gained prominence in ensuring its quality and stability in bulk and pharmaceutical formulations. This review systematically evaluates existing studies on RP-HPLC method development, emphasizing critical parameters such as mobile phase optimization, stress testing under forced degradation conditions, and method validation as per International Council for Harmonisation (ICH) guidelines. It further highlights analytical challenges and future perspectives in remdesivir quality control.

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2024-12-10
DOI
https://doi.org/10.5281/zenodo.14359085
Primary Topic
Analytical Methods in Pharmaceuticals
Type
article
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article

Stability-Indicating RP-HPLC Method Development and Validation for Estimation of Remdesivir in Bulk and Pharmaceutical Formulations: A Comprehensive Review

Zenodo (CERN European Organization for Nuclear Research)
Analytical Methods in Pharmaceuticals
article

Stability-Indicating RP-HPLC Method Development and Validation for Estimation of Remdesivir in Bulk and Pharmaceutical Formulations: A Comprehensive Review

article en

Abstract

The development of a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for remdesivir has gained prominence in ensuring its quality and stability in bulk and pharmaceutical formulations. This review systematically evaluates existing studies on RP-HPLC method development, emphasizing critical parameters such as mobile phase optimization, stress testing under forced degradation conditions, and method validation as per International Council for Harmonisation (ICH) guidelines. It further highlights analytical challenges and future perspectives in remdesivir quality control.

Zenodo (CERN European Organization for Nuclear Research)
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Analytical Methods in Pharmaceuticals
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