It is well known that regulations require verification of compendial HPLC methods and full analytical validation for non compendial methods, but what about the methods published in reputable journals? Why should I repeat the validation! I think verification which include specificity is enough, are you agree with me?
@ Bojidarka B. Ivanova
Regardless, either for routine analysis or stability study analysis.
Hi Mr Batrawi,
According to ISO 17025 (point 5.4.2 - 5.4.4). You must perform method validation for non standard method (non-compendia). Because the standard method should be pass the internal quality control, the proficiency test/interlaboratory test, and calculate its uncertainty. The other non-standard methods (i.e from international journals) is considered as in house analytical method, although they have been validated (in house).
In my opinion, if your reference paper(s) conduct not only validation method but also inter-laboratory or proficiency test, verification might be enough for ensuring this (or these) method(s) can be considered fit for intended purpose.
Dear Mr. Batrawi:
Greeting,,,
For me I prefer to do full validation for this published analytical method.
Scientific journals are not considered to include standard methods and any non standard method needs to be fully validated to ensure its suitability for intended use.
Best Regards
"Publication" of any method should never be considered as proof that the method is valid or even follows basic chromatography guidelines. Up to 20% of the articles I reviewed for some of the top professional research journals were completely invalid and indicated that the authors had little to no understanding of the technique or method used. This trend continues today with both "open" journals and so-called prestigious ones.
Never assume. Test, check and verify before use. It is good science to do so. As suggested by others, perform method validation before use. Optimize or revise as needed until it is fit for purpose and selective for the analyte.
Long story short, It is not possible to use published results unfortunately due to the reasons that Dion Notario indicated. According to ISO 17025 guidance, if the method set as a standard method by any authority such as AOAC, NIOSH, EPA etc. recovery study with certified materials/reference materials should be enough. Otherwise full scope validation including robustness & ruggedness, stability, LOD/LOQ, linearity, range intra, and inter-day repeatability, specificity must be performed for in-house method implementation.
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