EXTRACTION OF TRITON-X-100 AND ITS DETERMINATION IN VIRUS-INACTIVATEDHUMAN PLASMA BY THE SOLVENT DETERGENT METHOD

For inactivation of lipid-enveloped viruses during the production of f resh frozen and lyophilized human plasma, the solvent-detergent method was applied. In this process, the solvent tri-n-butyl phosphate is re moved by extraction with castor oil. The removal of the non-ionic dete rgent Triton X-100 is performed by solid-phase extraction using revers ed-phase supports. For this purpose, different polymer- and silica-bas ed supports were tested. The highest capacity for Triton X-100 was ach ieved with C-18 silica gels. These supports can bind more than 0.1 ml of Triton X-100 per ml of support. None of the proteins, e.g., clottin g factors, bind to the support and therefore they pass through the col umn and their biological activity is hardly affected. The determinatio n of detergent during the production process was also studied. The app lication of special columns allowing direct sample injection was intro duced. This is a simple method for the rapid in-process determination of Triton X-100 in human plasma by reversed-phase chromatography under isocratic conditions. Using the method developed here, less than 1.0 ppm of Triton X-100 can be detected in less than 12 min without any sa mple pretreatment.