method validation: specificity
Posted: Mon Sep 12, 2011 12:53 pm
i'm workin in a assay method for acetaminophen tablets based on USP method
how i demostrate the specificity?i have a UV detector no DAP
for example:
-retention time, second derivate (for matrix+analite respect an analite standrad)
-change % of components of movil fase
-using a diferent brand (brand with diferent selectivity or polarity)
-matrix (exipient): at 100% of work value
-analite (acetaminophen): at 100% of work value
-matrix + analite: matrix fixed concentration, analite in all work range and calculate the interference in %.
-what about impurity and degradation products: is necessary in my case?i only modify the volumes of the dilutions but not the final concentrations of standard and samples, and add a curve of calibrate for cuantification.
have not any information about this. How i do that?where i can get any information of this?
i thinks make an TLC but i don't know how.....
thanks
how i demostrate the specificity?i have a UV detector no DAP
for example:
-retention time, second derivate (for matrix+analite respect an analite standrad)
-change % of components of movil fase
-using a diferent brand (brand with diferent selectivity or polarity)
-matrix (exipient): at 100% of work value
-analite (acetaminophen): at 100% of work value
-matrix + analite: matrix fixed concentration, analite in all work range and calculate the interference in %.
-what about impurity and degradation products: is necessary in my case?i only modify the volumes of the dilutions but not the final concentrations of standard and samples, and add a curve of calibrate for cuantification.
have not any information about this. How i do that?where i can get any information of this?
i thinks make an TLC but i don't know how.....
thanks