ANYL 278 |
| Both empirical and computer-assisted optimization approaches were used for development of a HPLC analysis of impurities and degradants of a drug candidate. The method development goals were to improve resolution of a critical pair, while reducing the overall analysis time. In contrast to the empirical approach in which a considerable number of experiments were conducted to evaluate the effect of each of the multiple parameters on the separation, using the retention data from limited number of experimental runs, DryLab® software simultaneously optimized several key parameters in a few “virtual experiments”. Experimental results confirmed the DryLab® predicted optimum. Resolution of the critical pair was significantly improved and the run time was reduced using a simpler mobile phase system than that developed empirically. Alternative even faster conditions could also be predicted, but were shown experimentally to be impracticable due to tailing of the main peak limiting resolution of a closely-eluting impurity. This example illustrates the utility of software such as DryLab® in understanding the analytical design space; based on the model predictions, more realistic expectations were set for how much the method speed could be increased. |
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Analytical Approaches: Separation Science
1:30 PM-5:00 PM, Wednesday, 13 September 2006 Moscone Center -- Room 130, Oral
Division of Analytical Chemistry |