Analytical method validation - accuracy

[saipraveen7]

Can anyone explain me on how to do accuracy (recovery) study in analytical method validation by HPLC for API (pure bulk drug) as no placebo will be available for the recovery study

[Gerhard Kratz]

But anyhow you Need your API as a pure reference Standard. If it is a known API than look for sources where you can buy that API as a reference Standard. If it is a new API than you can define your own Standard. Do LCMS and NMR and prouve that your "Standard" is X% pure. Good documentation is a must. Good luck

[HPLCaddict]

As you already imagined yourself, recovery experiments cannot be used for the pure API to verify accuracy.
ICH Q2 suggests in this case:
"Several methods of determining accuracy are available:
a) application of an analytical procedure to an analyte of known purity (e.g. reference
material);
b) comparison of the results of the proposed analytical procedure with those of a second
well-characterised procedure, the accuracy of which is stated and/or defined;
c) accuracy may be inferred once precision, linearity and specificity have been
established."