1 Department of R and D, Precise Biopharma Private Limited, Turbhe, Navi Mumbai, Maharashtra, India.
2 Department of Analytical Development, Precise Biopharma Private Limited, Turbhe, Navi Mumbai, Maharashtra, India.
World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 487-496
Article DOI: 10.30574/wjbphs.2025.22.1.0430
Received on 14 March 2025; revised on 21 April 2025; accepted on 23 April 2025
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.
Semaglutide; HPLC; Manufacturing equipment; Quality control department
Preview Article PDF
Sunil Sukthankar, Sandesh Parab, Milind Pawar and Ruturaj Vichare. Development and validation of HPLC method for determination of amino acid mole ratio in Semaglutide. World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 487-496. Article DOI: https://doi.org/10.30574/wjbphs.2025.22.1.0430.