Development and validation of HPLC method for determination of amino acid mole ratio in Semaglutide

This study describes the development and validation of HPLC method for determination of amino acids mole ratio in Semaglutide. System suitability, specificity, Linearity and Range, Precision at specification level and Solution stability, Accuracy were studied to ensure amino acid mole ratio. The analytical method used for determination of amino acid mole ratio. System Suitability, Specificity, Linearity and range, Precision at specification level, and Accuracy. Hence, the method stands validated. The method can be used routinely for determination of amino acid mole ratio in Semaglutide in the quality control department.

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Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-04-30
DOI
https://doi.org/10.5281/zenodo.17377874
Primary Topic
Analytical Methods in Pharmaceuticals
Type
article
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article

Development and validation of HPLC method for determination of amino acid mole ratio in Semaglutide

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

Development and validation of HPLC method for determination of amino acid mole ratio in Semaglutide

article en

Abstract

This study describes the development and validation of HPLC method for determination of amino acids mole ratio in Semaglutide. System suitability, specificity, Linearity and Range, Precision at specification level and Solution stability, Accuracy were studied to ensure amino acid mole ratio. The analytical method used for determination of amino acid mole ratio. System Suitability, Specificity, Linearity and range, Precision at specification level, and Accuracy. Hence, the method stands validated. The method can be used routinely for determination of amino acid mole ratio in Semaglutide in the quality control department.

Zenodo (CERN European Organization for Nuclear Research)
Precise (India) (IN), Navidea Biopharmaceuticals (United States) (US)
Openalex Percentile: Top 49%
Analytical Methods in Pharmaceuticals
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