药用胶塞硫化剂对叔辛基苯酚甲醛树脂中对叔辛基苯酚的测定

Determination of Octylphenol from Octyl-phenolic Curing Resin in Rubber Stoppers for Pharmaceutical Use

建立了高效液相色谱法测定药用胶塞硫化剂对叔辛基苯酚甲醛树脂中的对叔辛基苯酚单体。考察对叔辛基苯酚在不同提取介质中的提取量,以研究其在不同介质中的迁移情况。采用Agilent C18色谱柱,75%甲醇为流动相,检测波长280 nm。对叔辛基苯酚在0.35~104μg/ml范围内线性关系良好,在p H 3.0、p H 7.0、p H 11.0磷酸盐缓冲液以及10%、50%、100%乙醇中的回收率均介于90%~105%,RSD小于5%。

An HPLC method was established for the determination of octylphenol, which was the residual monomer of octyl-phenolic curing resin, a vulcanizing agent, in rubber stoppers for pharmaceutical use. The extracted amount of octylphenol in different extractants, as well as the migration of octylphenol to the extractants were investigated. An Agilent C18 column was used, with the mobile phase of 75 % methanol, at the detection wavelength of 280 nm. It was linear in the concentration range of 0.35-104 μg/ml. The average recoveries were all in a range of 90%-105% （RSD〈5.0%） in pH 3.0, oH 7.0, oH 11.0 phosphate buffer solutions and 10%, 50%,100% ethanol.