What are the parameters to be addressed in method validation of Titrimetric methods.?
Specificity, Precision, Accuracy, Linearity and range and Robustness. Which are the parameters to be included and which are to be deleted?
Thanks in advance
[quote=snagabiru]What are the parameters to be addressed in method validation of Titrimetric methods.?
Specificity, Precision, Accuracy, Linearity and range and Robustness. Which are the parameters to be included and which are to be deleted?
Thanks in advance[/quote]
Delete Accuracy and Robustness.
Why to delete accuracy:
In linearity, we use standard with in a range 80-120% of the given test weight and verify the linearity for weight of the standard and and volume of titrant.
Fortunately we can calculate assay of those concentrations which covers the accuracy.
ICH Statement on Accuracy:
“Application of an analytical procedure to an analyte of known purity (e.g. reference material)”
So Accuracy is not needed to do once again, If linearity is inferred.
Why to delete Robustss :
You can not do any deliberate changes to a titration method.[ since the method contains test sample and volumetric solution]
Intermediate precision can be included.
Best Regards,
Bujji kanchi.
hi,
How do you perform Specificity of titrimetric method?
Are u comparing standard with Test titrations?
Literally speaking
- specificity is not possible with Titrimetric methods. These are not stability indicating methods.
- Linearity is not required since the reactions are mole to mole in titrations.
Hence the range is valid for unlilmited concentrations.
Since the titration is a non specific method, It is compensated by impurity testing during release.
One kind of practice for specificity is performing blank titration and it should be less than 0.1 ml consumed.
Regards,
Bujji Kanchi.