Automated data processing for chromatographic assay method validations

A set of computer programs has been developed for the automated transfer, storage, and processing of data related to chromatographic pharmaceutical assay method validations. These programs calculate and report statistical parameters relating to the resolution, linearity of response, and precision of an assay method based upon peak width, retention time, and integration data provided by a commercial chromatographic data system. Utilization of an interface between the data system and a microcomputer minimizes manual handling of all data. Techniques and equations used in the development of the software are described, and an application to the validation of a high performance liquid chromatographic assay method for a bulk drug substance is demonstrated.