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目的:建立颜料棕25和UV-327的痕量检测方法,对一次性使用避光过滤输液器中颜料棕25和UV-327的迁移溶出进行研究。方法:采用高效液相色谱法,颜料棕25选用Inertsil ODS-3色谱柱,以乙腈-0.1%磷酸(80∶20)为流动相,流速1.0m L·min-1,415 nm作为检测波长;UV-327选用Zorbax-C18色谱柱,以甲醇-水(95∶5)为流动相,流速1.2 m L·min-1,346 nm作为检测波长。结果:颜料棕25质量浓度在5.06~404.8 ng·m L-1范围内线性关系良好(r=0.999 9),平均回收率为100.5%,检出限为1.518 ng·m L-1;UV-327质量浓度在1.163~116.3 ng·m L-1范围内线性关系良好(r=0.999 9),平均回收率为101.0%,检出限为0.383 8 ng·m L-1;颜料棕25和UV-327在65%乙醇溶液、0.1 mol·L-1氢氧化钠溶液、0.1 mol·L-1盐酸溶液和8种临床输液药物中未发生溶出。结论:本文建立的方法灵敏度高,重复性好,适合对避光输液器中颜料棕25和UV-327的迁移溶出进行检测;颜料棕25和UV-327适合作为输液器的避光材料。
OBJECTIVE: To establish a method for the trace detection of Pigment Brown 25 and UV-327, and to study the migration and dissolution of Pigment Brown 25 and UV-327 in the disposable evaporative filter infusion set. Methods: Inertsil ODS-3 was used in the determination of pigment brown 25 with acetonitrile-0.1% phosphoric acid (80:20) as mobile phase at a flow rate of 1.0 m L · min-1 and 4.15 nm as detection wavelength by high performance liquid chromatography 327 selected Zorbax-C18 column with methanol-water (95: 5) as the mobile phase, the flow rate of 1.2 m L · min-1,346 nm as the detection wavelength. Results: The average recovery was 100.5% and the detection limit was 1.518 ng · m L-1 with a good linearity (r = 0.999 9) in the range of 5.06 ~ 404.8 ng · m L-1. The calibration curve was linear over the range of 1.163-116.3 ng · m L-1 (r = 0.999 9) with an average recovery of 101.0% and a detection limit of 0.383 8 ng · m L-1. Pigment Brown 25 and UV -327 did not dissolve in 65% ethanol solution, 0.1 mol·L-1 sodium hydroxide solution, 0.1 mol·L-1 hydrochloric acid solution and 8 clinical infusion solutions. Conclusion: The method proposed in this paper has high sensitivity and repeatability, and is suitable for the detection of migration and dissolution of Pigment Brown 25 and UV-327 in the light-infusing infusion set. Pigment Brown 25 and UV-327 are suitable as light-shielding materials for infusion sets.