Analytical Method Development And Validation Of Impurity Profile In Semaglutide

An accurate and precise analytical method was developed to profile the contaminants in semaglutide API.The HiQSil C18 column (250 mm 4.6 mm, 5 m) was employed to optimise the mobile phase for enhanced impurity separation at 35 C.The mobile phase had a 65:35 (v/v) ratio of water to methanol.The mobile phase was delivered at a rate of 1.0 mL/min.The chromatogram was seen at 230 nm, and the mobile phase was modified to enhance resolution.Between the LOQ level and 150%, a recovery rate of 90% for semaglutide was found.The correlation coefficient (r2) for semaglutide and its impurities I, II, and III was found to exceed 0.998.In the robustness study, it was found that the approach remained impervious to variations in method variance.The established method is suitable for routine analysis of semaglutide in the quality control laboratory due to its robustness, accuracy, precision, and linearity.