避光输液器中颜料棕25和UV-327的迁移溶出研究

发布时间：2018-05-03 01:19

本文选题：药品包装材料 + 避光输液器　；参考：《药物分析杂志》2015年06期

【摘要】：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。
[Abstract]:Objective: to establish a trace determination method for pigment brown 25 and UV-327, and to study the migration and dissolution of pigment brown 25 and UV-327 in a one-off filter infusion device. Methods: high performance liquid chromatography (HPLC), Inertsil ODS-3 column for pigment brown 25, acetonitrile-0.1% phosphoric acid 80: 20) as mobile phase, flow rate 1.0 mL min-1415 nm as detection wavelength and Zorbax-C18 column as detection wavelength, methanol-water 95: 5) as mobile phase. The flow rate was 1.2 mL min-1346 nm as the detection wavelength. Results: the calibration curve of pigment brown 25 was linear in the range of 5.06 ~ 404.8 ng mL ~ (-1), the average recovery was 100.5, the detection limit was 1.518 ng m ~ (-1) and UV-327 was 1.518 ng 路L ~ (-1) ~ (-1) in the range of 1.163 ~ 116.3 ng m ~ (-1) ng 路mL ~ (-1). The average recovery was 101.0 ~ (-1) and the detection limit was 10 ~ (10) cm ~ (-1). 0.383 ng mL -1, pigment brown 25 and UV-327 were not dissolved in 65% ethanol solution, 0. 1 mol L -1 sodium hydroxide solution, 0. 1 mol L -1 hydrochloric acid solution and 8 clinical infusion drugs. Conclusion: the method developed in this paper is sensitive and reproducible, and is suitable for the detection of the migration and dissolution of pigment brown 25 and UV-327 in the device, and the pigment brown 25 and UV-327 are suitable for the light protection material of the infusion device.
【作者单位】：淄博市食品药品检验检测中心;
【分类号】：R927.2;O657.72

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