Research Information System
INTERNATIONAL JOURNAL OF PEPTIDE RESEARCH AND THERAPEUTICS, vol.31, no.2, 2025 (SCI-Expanded)
PurposeIn this study, a new greenness size exclusion chromatographic method has been developed and validated for the determination of semaglutide used as an antidiabetic agent in pharmaceutical formulations.MethodsA new HPLC method for refractive index detection was developed for the determination of semaglutide in the subcutaneous and oral formulation samples. The validation of the developed method was performed according to International Conference on Harmonisation guidelines Q2 (R1). The eco-friendliness of the method was evaluated utilizing the automated AGREE tool, and the overall score of 0.85 indicated a relatively environmentally friendly HPLC method.ResultsThe limits of detection and quantification were calculated to be 13.18 mu g/mL and 43.95 mu g/mL, respectively. The assay recovery and precision of semaglutide from subcutaneous and oral formulations at 0.1, 0.5, and 1.0 mg/mL concentrations were evaluated. The mean recoveries for semaglutide in the subcutaneous and oral formulations were calculated as 99.66-100.16% and 99.20-99.98%, respectively, using the standard addition method.ConclusionThe validated method was successfully applied to the determination of semaglutide in subcutaneous and oral formulations. The proposed method is green, cheap, fast, and simple and can be used safely for routine analysis. Also, it is an environmentally friendly method in terms of the chemicals used in the method.