Is specificity should be done during the method validation or should be done during the method development work ?
i think specificity is the part of method development not the method validation becasue you can modify the method if there is any interfering peak during the method development.
[COLOR=“DarkOliveGreen”]I also agree that it is part of method development but VALIDATION IS DOCUMENTED PROOF THAT U HAVE DONE SPECIFICITY.
ALSO USP STATES THAT SPECIFICITY DEFINATION HAS FOLLOWING IMPLICATIONS.
1 Identity: Identity of analyte
2 Purity test: content of impurities of an analyte (at time of validation)
3 Assay: accurate statement on the content of potency of the analyte in the sample[/color]
[quote=vjp]Is specificity should be done during the method validation or should be done during the method development work ?
i think specificity is the part of method development not the method validation becasue you can modify the method if there is any interfering peak during the method development.[/quote]
Method development involves certain hit n try, and mostly data generated during method development is not properly recorded, so after optimization of method u have to perform method validation with all stated parameters in written protocol. Yes u can play smart here, u can use the suitable data generated during method development.
Concerning specificity, do you mean that in case of the same active in different formulations (active doses and excipients) analyzed with the same analytical method, injecting the same analyte concentration it would be sufficient revalidate specificity and accuracy for assay, and specificity, stress test, LOD/LOQ and accuracy for degradants?
Thanks to all.
Sheila