【摘要】 文章建立了避光型热塑性聚氨酯输液器中紫外线吸收剂UV-P迁移量的高效液相色谱检测方法，对一次性使用聚氨酯输液器中紫外线吸收剂UV-P的溶出性质进行研究。以6种不同类型的注射液模拟临床使用条件，经聚氨酯输液器输注后进高效液相色谱仪进行分析。采用Kromasil C₁₈色谱柱，以甲醇-水（90∶10）为流动相，339 nm为检测波长。结果表明：UV-P在0.061 4～1.638 0 mg/L质量浓度范围内线性关系良好（r=0.999 9），各输液平均加标回收率均在97.51%～101.10%，相对标准偏差（RSD）小于2%，信噪比大于3，检测下限为0.020 48 mg/L。文章建立的方法灵敏度高、重复性好，适合对聚氨酯输液器中UV-P的溶出量进行检测。更多还原

【Abstract】 This paper established a high performance liquid chromatography（HPLC） method for the determination of ultraviolet absorber UV-P in an light resistant thermoplastic polyurethane infusion device, and to carry out the research on the dissolution of ultraviolet absorber UV-P from disposable TPU infusion device. Six different types of injections were used to simulate the clinical application conditions, and after infusion with a light resistant TPU infusion device, they were analyzed by high-performance liquid chromatography. Kromasil C₁₈ column was adopted, the mobile phase consisted of methanol-water（90∶10）, the detection wavelength was 339 nm. The resuls show that calibration curves of UV-P are linear over the range of 0.061 4～1.638 0 mg/L（r=0.999 9）, the average recoveries are both betwen 97.91% and 101.10%, the relative standard deviation is less than 2%, the signal-to-noise ratio is greater than 3, and the values of quantitation limit is 0.020 48 mg/L.The method is sensitive and good repeatability, which is suitable for the detection of UV-P dissolution in TPU infusion device.更多还原