Analysis of Sorbitol According to USP-NF Method (SP0810 8C)
Exenatide is a peptide consisting of 39 amino acids that is widely used as a type 2 diabetes drug for GLP-1 analogues. According to the United States Pharmacopeia and the National Formulary (USP-NF) method, for the assay of exenatide injection sorbitol, a column packed with L 20 packing is recommended for the analysis. It is necessary for the system suitability to satisfy, resolution of exenatide/soybean trypsin inhibitor of 1.3 or more, the tailing factor of exenatide of 0.8 to 1.4, and relative standard deviation (RSD) for exenatide of not more than 2.0%. Analysis using PROTEIN KW-802.5（L20）meets all the system suitability requirements.