避光输液器中颜料棕25和UV-327的迁移溶出研究

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1.0 mL·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 mL·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·mL^-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·mL^-1;UV-327质量浓度在1.163~116.3 ng·mL^-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·mL^-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 trace determination of Pigment Brown 25 and UV-327 so as to explore the migration and dissolution of Pigment Brown 25 and UV-327 from disposable light-proof infusion set. Methods: Pigment Brown 25 was detected by high performance liquid chromatography(HPLC)method.The Inertsil ODS-3 column was adopted;the mobile phase consisted of acetonitrile -0.1% phosphate acid(80:20)at a flow rate of 1.0 mL·min^-1;the detection wavelength was 415 nm.For UV-327,the Zorbax-C₁₈ column was adopted;the mobile phase consisted of methanol-water(95:5)at a flow rate of 1.2 mL·min^-1;the detection wavelength was 346 nm. Results: The calibration curves of Pigment Brown 25 and UV-327 were linear over the range of 5.06-404.8 ng·mL^-1(r=0.999 9)and 1.163 -116.3 ng·mL^-1(r=0.999 9);the average recoveries were 100.5% and 101.0%;the quantitation limits were 1.518 ng·mL^-1 and 0.383 8 ng·mL^-1.Pigment Brown 25 and UV-327 were not dissolved in 0.1 mol·L^-1 hydrochloric acid,0.1 mol·L^-1 sodium hydroxide,0.1 mol·L^-1 hydrochloric acid as well as in 8 infusion solutions. Conclusion: The method is sensitive and reproducible,which is suitable for the dissolution test of Pigment Brown 25 and UV-327 in disposable light-proof infusion set.Pigment Brown 25 and UV-327 is suitable to be used as the light-proof materials of infusion set.

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