| Pharmaceutical macromolecular analysis techniques,after the development of immunofluorescence(IFA)in the 1950 s and radioimmunoassay(RIA)in the 1960 s,enzyme-linked immunosorbent assay(ELISA)was established in the early 1970 s.Exenatide is the synthetic products of GLP-1 analog exendin-4,consisting of 39 amino acids,poor stability.This medicine is used to improve blood sugar control in patients with type 2 diabetes,suitable for the patients who single use of metformin,sulfonylureas and metformin in combination with sulfonylureas,while still have a poor blood glucose control.It is necessary to establish a quick and accurate analytical nethod for exenatide in practical applications.With the development of modern analytical techniques,continuous research on the LC-MS/MS analysis technology has provided a simpler and faster analysis method for the analysis and identification of metabolites in medicine.LC-MS/MS technology combines the high-resolution capabilities of liquid chromatography with the structural information provided by mass spectrometry.It has the advantages of high sensitivity and selectivity,and in particular,tandem mass spectrometry(MS/MS or MS)performs better.A rat model of type 2 diabetic rats(T2DM)was established by combination of streptozotocin with high-fat and high-sugar diet.ELISA and LC-MS/MS test T2 DM rat sample escitatide content,the experimental study showed that compared with the normal group,FFA levels in the serum of the model group rats were significantly increased(P > 0.05)4 weeks after the high-fat and high-sugar diet.After 72 hours of combined tail vein injection of STZ,the fasting blood glucose level of the model group was significantly higher than that of the normal group(P > 0.05).Conforms to type 2 diabetes characteristics,the lowest concentration on the ELISA was: 781 ng/mL;the lowest concentration on the LC-MS/MS was 10 ng/mL.Therefore,LC-MS/MS was more accurate in the determination of plasma exenatide in type 2 diabetic rats. |
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