Design of experiment and data analysis by JMP (SAS institute) in analytical method validation.

Validation of an analytical method through a series of experiments demonstrates that the method is suitable for its intended purpose. Due to multi-parameters to be examined and a large number of experiments involved in validation, it is important to design the experiments scientifically so that appropriate validation parameters can be examined simultaneously to provide a sound, overall knowledge of the capabilities of the analytical method. A statistical method through design of experiment (DOE) was applied to the validation of a HPLC analytical method for the quantitation of a small molecule in drug product in terms of intermediate precision and robustness study. The data were analyzed in JMP (SAS institute) software using analyses of variance method. Confidence intervals for outcomes and control limits for individual parameters were determined. It was demonstrated that the experimental design and statistical analysis used in this study provided an efficient and systematic approach to evaluating intermediate precision and robustness for a HPLC analytical method for small molecule quantitation.