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目的:建立一种测定氨磷汀聚乳酸乙醇酸共聚物(PLGA)微球中氨磷汀含量的方法。方法:样品与荧光胺试剂碱性条件下衍生化后,以Agilent HC-C18柱(250mm×4.6mm,5μm)分离,以乙腈-水-10%磷酸溶液(25∶75∶1)为流动相,流速为1mL.min-1,以荧光检测器检测,激发波长为395nm,发射波长为480nm。结果:氨磷汀样品在0.4～4.0mg.L-1范围内与其峰面积有良好的线性关系(r=0.999 9)。低、中、高3个浓度的回收率(n=9)分别为95.83%,94.66%,96.15%;RSD分别为1.6%,1.8%,1.5%。结论:该方法灵敏度高,准确迅速,重复性好,能够满足氨磷汀微球中氨磷汀含量的分析测定。
OBJECTIVE: To establish a method for the determination of amifostine in amylin-polylactic acid glycolic acid (PLGA) microspheres. Methods: After the sample was derivatized with fluorescamine reagent under basic conditions, the sample was separated on an Agilent HC-C18 column (250 mm × 4.6 mm, 5 μm) using acetonitrile-water 10% phosphoric acid (25:75:1) as mobile phase , The flow rate of 1mL.min-1, with fluorescence detector detection, excitation wavelength of 395nm, emission wavelength of 480nm. Results: Amifostine had a good linear relationship with its peak area in the range of 0.4 ~ 4.0 mg.L-1 (r = 0.999 9). The recoveries of low, medium and high concentrations (n = 9) were 95.83%, 94.66% and 96.15% respectively, and the RSDs were 1.6%, 1.8% and 1.5% respectively. Conclusion: The method is sensitive, accurate and rapid, reproducible, and can meet the determination of amifostine in the microspheres of amifostine.