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- Posts: 5
- Joined: Thu Dec 16, 2010 7:20 am
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