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《高等学校化学研究：英文版》
>Development and Validation of a Reverse-phase High Performance Liquid Chromatography Method for Determination of Exenatide in Poly(lactic-co-glycolic acid) Microspheres
Development and Validation of a Reverse-phase High Performance Liquid Chromatography Method for Determination of Exenatide in Poly(lactic-co-glycolic acid) Microspheres
Exenatide(synthetic exendin-4), which has been approved by the Food and Drug Administration(FDA) for the adjunctive treatment of patients with type 2 diabetes, is an incretin mimetic agent. The development and validation of a RP-HPLC method for the quantification of the exenatide in poly(lactic-co-glycolic acid)(PLGA) microspheres is described. Separation was performed on a C4 column via a mobile phase consisting of ACN:KH2PO4(0.02 mol/L, pH=2.5) gradient elution from 30:70 to 45:55(volume ratio) in 30 min. Multi-diode array detection(DAD) appears to be most appropriate to evaluate the spectral purity of exenatide. The limits of detection and quantification of exenatide were 0.4 and 1.2 μg/mL, respectively. The calibration curve of exenatide was linear in a range of 0.025―0.2 mg/mL with a correlation coefficient of 0.9995. The results of validation study show that this method is specific, accurate(recovery>95%), precise(RSD<2.0%) and robust.
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