I did robustness parameter for a method among all the parameters, my method is failing in low column oven temperature and high solvent ratio. On the basis of other parameters like pH and spl extraction, can I say my method is ok? Please give any suggestions links to related documents.
Robustness is usually evaluated as part of method development. It is not a parameter that is usually associated with pass or fail. Rather this validation phase gives the method developer the opportunity to identify those method parameters that are critical to the optimum performance of the method and assign system suitability parameters that will help ensure validity of data. Once critical parameters are identified, a suitable precautionary statement should be added to the written method.
Did u have any written evidence anywhere in guidelines if yes please send me at [email protected]
Search for ICH document Q2(R1), Validation of Analytical Procedures: Text and Methodology.
In addition, I would like suggest this Eurachem guide: A Laboratory Guide to Method Validation and Related Topics.
It can be downloaded at this link http://www.eurachem.org/images/stories/Guides/pdf/valid.pdf
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