Abstract

An expert system is described for the design and diagnosis of the results of a ruggedness test in HPLC method validation. It advises on the selection of relevant factors and an appropriate experimental design and it translates the statistical results into chemically relevant results. If the test fails, the program can advise on how to improve the HPLC method. The basis of the program is a Common Data Structure which represents all objects that are important in HPLC. Linked to this Common Data Structure are modules that manipulate objects. The modules represent major steps in a ruggedness test. An expert system on factor choice and a program on solving resolution problems are integrated in this program as modules. The program is designed to advise on a complete ruggedness test, from factor choice to improvement of the method.

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