Kersten B S
Searle Research and Development, Skokie, Illinois 60077.
J Chromatogr Sci. 1992 Apr;30(4):115-9. doi: 10.1093/chromsci/30.4.115.
A wide-bore capillary gas chromatographic method has been developed to study the drug matrix effect on the determination of residual solvents in bulk pharmaceuticals. A selective method is achieved on a Restek wide-bore (0.53-mm i.d. x 30 m) open-tubular fused-silica column coated with a 5-micron film of 95% dimethyl-5% diphenyl polysiloxane protected by a phenyl-methyl siloxane deactivated, uncoated fused-silica guard column. Utilizing this method, several common process solvents in weakly acidic, weakly basic, and neutral drug matrices are evaluated by recovery and linearity studies to show whether or not a drug matrix effect exists in their determination.
已开发出一种宽口径毛细管气相色谱法，用于研究药物基质对原料药中残留溶剂测定的影响。在Restek宽口径（内径0.53毫米×30米）开口管熔融石英柱上实现了一种选择性方法，该柱涂有5微米厚的95%二甲基-5%二苯基聚硅氧烷薄膜，并由苯基甲基硅氧烷钝化的未涂覆熔融石英保护柱保护。利用该方法，通过回收率和线性研究对弱酸性、弱碱性和中性药物基质中的几种常见工艺溶剂进行评估，以表明在其测定中是否存在药物基质效应。
