COMMON PROBLEMS AND SOLUTIONS

1.Presentation of method validation data. Table 3.2 provides a quick over-

view of the validation data.

2.System suitability. During the robustness testing of method validation, criti-

cal method parameters such as mobile phase composition and column temperature

are varied to mimic the day-to-day variability. Therefore, the system suitability

results from these robustness experiments should reflect the expected range for the

system suitability results. As a result, system suitability results in these method

validationexperimentsareveryusefulindeterminingthesystemsuitability

acceptance criteria. This is a very effective approach since the required system

suitability results can be generated during method validation and no other special

study is required. However, these results reflect the expected performance of the

system, but not necessarily the minimum performance standard for acceptable

results. For example, the minimum resolution of the critical pair from method

validation may be 3.5; however, a resolution of 2.0 may still be acceptable as

longas theyare baselineresolvedandallotherchromatographicparameters

remain acceptable.