Chromatography Forum

Dear friends,

I have to validate a HPLC method for assay and impurity.
In our method, there is four peaks, one is main component and other three are impurities.We are taking only relative area% from HPLC chromatogram. Assay is calculated as:

Assay by HPLC = Assay by UV x HPLC area% of main component/100.

Imurities is reported directly as area%.

In ICH guideline there is two type of imp. test, one is quantitative and other is limit test.
For limit test, prescribed validation parameter is 'Specificity' & 'LOD'. For quantitative test more parameters prescribed.

Now I want to know which parameter I have to follow for validation of our method.


Thanks & regards
Mritunjai

A "Limit Test" is essentially "go / no go". You do not report the actual amount, only whether the material is present or absent. So:

If you are measuring and reporting the amount, then it is *not* a Limit Test and thus you must do the "full" validation. If you are only reporting "found / not found", then it is a Limit Test and the simpler validation is OK.

Thanks
I got it.


Regards.
Mritunjai