Abstract

Method validation is increasing in importance as higher standards of precision and accuracy are required. The validation of liquid chromatographic methods requires the examination of selectivity, sensitivity, accuracy, precision and limitations, depending on the purpose of the method. The precision is affected by the repeatability of procedural steps (e.g., injection), within the method and by its overall reproducibility (e.g., interlaboratory reproducibility). The application of spreadsheets with an expert system to evaluate these effects is described. The spreadsheets are programmed to produce the necessary statistics. Rules are defined for the expert system to interact with these to select suitable tests for different applications, to set up spreadsheets into which the analyst inputs the data, and to interpret the data processed in the spreadsheet. The system is tested with a repeatability study of the separation of aspirin and salicylic acid. A combination of the Goldworks software for development of expert systems and the Lotus 1-2-3 spreadsheet package was used.

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