Chromatography Forum

Is spike recovery could be best way to show the accuracy of the analytical method or other better way if yes let me know. The way of showing accuracy could be different by different chromatographic method like SEC,IEC,RP etc.

Depends on what’s the goal of the analysis. If determination of a compound (drug substance for instance) in a complex matrix (a pharmaceutical formulation for instance) is the aim, then spiking is probably the most convincing method – especially if the separation is less than perfect! Otherwise (if analysis of a single compound (“pureâ€

"The way of showing accuracy could be different by different chromatographic method like SEC,IEC,RP" - the same, reading some guidlines can give you some more understanding, start with ICH Q2

"Is spike recovery could be best way to show the accuracy of the analytical method" - recovery study is probably most widely used, what is best for you may not be best for someone else

One other way of doing accuracy is analysing the sample in an alternate method and comparing the values.
This technique would be typically used for NCE s as a one component system.

My knowledge is with drug formulations (mainly syrups and suspensions). The best way I have found is to spike placebo with known concentrations of the API (usually at 80%,100% and 120%) in triplicate prep and inject in duplicate. I will typically put a 97-103 or a tighter 98-102 recovery spec for the accuracy

My knowledge is with drug formulations (mainly syrups and suspensions). The best way I have found is to spike placebo with known concentrations of the API (usually at 80%,100% and 120%) in triplicate prep and inject in duplicate. I will typically put a 97-103 or a tighter 98-102 recovery spec for the accuracy

I do very similar for the Accuracy requirement. Actually, “METHODS, METHOD VERIFICATION AND VALIDATIONâ€