Journal
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Volume 23, Issue 2-3, Pages 581-589Publisher
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/S0731-7085(00)00335-6
Keywords
validation; design of experiment; precision; robustness; HPLC
Categories
Ask authors/readers for more resources
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 ii Small molecule in drug product in terms of intermediate precision and robustness study. The data were analyzed in JMP(R) (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. (C) 2000 Elsevier Science B.V. All rights reserved.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available