HPLC method validation

[ltnguy3]

If I use the HPLC method from USP, do I have to do full validation for this method or just partial validation? For the partial validation, Is it O.K to do accuracy, precision, robustness only?
Thanks,

[Dan]

LV,

As the USP method is already validated, you do not have to validate it.

First Caveat:
However, you do need to show that the USP method is (or is not) appropriate for your product. So you do what has been termed "verification" of the USP method.

Second caveat:
In the places where I have worked (pharmaceutical GMP labs), there has never been a clear definition of what experiments are required to be performed to verify a USP method. So we end up doing all of the normal validation experiments that we would normally do for an in-house developed method.

As a personal recommendation, I would say perform placebo interference, accuracy and perhaps repeatability.

Regards,
Dan

[ltnguy3]

Dan,
Thanks for your recommendation.