Dear Sir'
Im trying to validate an HPLC method for antioxidant analysis and this is the first time I will do it . So can you help me in the following topics:
_Acceptance criteria for Linearity,Accuracy,Precession and Specificity.
_Is the analytical method should be a stability indicating method or not.
Thanks.
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By Anonymous on Saturday, September 14, 2002 - 03:02 am:
We are validating our methods for antioxidants in the same way as our methods for active ingredients.
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By Melissa on Saturday, September 14, 2002 - 03:21 pm:
www.waters.com has a good section on method validation.
Basically the criteria depend on your method. Is this trace analysis or a method that requires more precision.
A stability indicating assay is an analytical method that accurately quantitates the active ingredients in the presence of degradation products, excipients, and other impurities. This is under the specificity section of the validation protocol and requires degradation studies.