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Re-validation
Posted: Fri Oct 07, 2011 6:55 pm
by agentile
Hi all, could anyone tell me which kind of tests should I try if I intend to perform an analytical method validated in an HPLC with a standard DAD detector to another HPLC with a more sensitive DAD detector?
Thank you in advance.
Re: Re-validation
Posted: Fri Oct 07, 2011 7:56 pm
by HPLCaddict
If the detector is more sensitive than the original one, I wouldn't expect big problems. Signal/Noise ratio might be checked, if you're working with low concentrations, but it should be better with the more sensitive detector.
One thing often forgotten might be to check which detector settings (sampling rate!) are appropriate with the newer one...
Honestly, I wouldn't expect a formal revalidation to be necessary...
Re: Re-validation
Posted: Fri Oct 07, 2011 11:58 pm
by tom jupille
I agree with HPLCaddict: so long as you pass system suitability on the new system, revalidation should not be necessary.
Re: Re-validation
Posted: Mon Oct 10, 2011 7:50 am
by Alex Buske
I agree with HPLCaddict: so long as you pass system suitability on the new system, revalidation should not be necessary.
That is true if the SST contains a "sensitivity criterion". If it hasn't, compare the S/N of low concentration standard.
On the other side, if you work at higher absorption (500-1500mAU), it would be sensible to check linearity.
Alex