Chromatographic method development: computer simulated statistical design approach

Abstract

The computerization of method development and validation are useful in analysis of pharmaceuticals in
pharmaceutical industry. In this article a simple and rapid high performance liquid chromatographic
method has been developed for the determination of oxcarbazipine in pharmaceutical formulations.
Factorial design was applied for optimization of essential factors for robustness study. A linear model
was postulated and a 23
full factorial design was employed to estimate the model coefficients. More
specifically, experimental design helps the researcher to verify if changes in factor values produce a
statistically significant variation of the observed response. The strategy is most effective if statistical
design is used in most or all stages for screening and optimizing process in future method validation
for method development and validation.
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