How can I validate a HPLC prep method?
In short, the process is like that : DNA oligos are synthesised, then purified on a HPLC prep, and finally analyzed by the QC.
Our QC, use an analytical HPLC. And the methods are all validated according to ICH guidelines (repeatability, specificity, linearity and accuracy// LOD LOQ are not studied because we don’t quantify on HPLC).
I don’t think that all of these parameters need to be verified on a HPLC prep method, isn’t it?
HPLC prep method validation has to be lighter then analytical method validation.
Sorry for the mistakes,