RES, AN EXPERT SYSTEM FOR THE SET-UP AND INTERPRETATION OF A RUGGEDNESS TEST IN HPLC METHOD VALIDATION .1. THE RUGGEDNESS TEST IN HPLC METHOD VALIDATION

In method validation, an intralaboratory repeatability study and an interlaboratory reproducibility study can be performed as part of a precision test. In HPLC, an intralaboratory ruggedness test can be performed to detect problems that would otherwise be encountered in a reproducibility study. In a ruggedness test, variations in ambient factors that are expected to occur in practice, are simulated. Several steps determine the success of a ruggedness test. The complexity and lack of standard procedures for some of these steps is the main reason why ruggedness testing is still not widely accepted.