Accuracy vs recovery

Hi,

I need an advise of how to establish accuracy of the API method. Could accuracy be inferred from linearity? Since this is an API there is no matrix interference or anything and 100% recovery is expected. I am not sure this is a correct approach though.
Would injecting sample of known concentration and calculating the result based on linearity curve build previously with the same substance give better estimation of method’s accuracy?

Thank you.

[quote=ruth_j]Hi,

I need an advise of how to establish accuracy of the API method. Could accuracy be inferred from linearity? Since this is an API there is no matrix interference or anything and 100% recovery is expected. I am not sure this is a correct approach though.
Would injecting sample of known concentration and calculating the result based on linearity curve build previously with the same substance give better estimation of method’s accuracy?

Thank you.[/quote]

i would use the standard addition method of determining the accuracy. This way you would eliminate the bias generated as a result of using the same standard to measure against the linearity test, and eliminate the “secondary” standard problem you appear to have.

Hope this helps…

In API test method there is no requirment of recovery or accuracy since there is no matrix