robustness study!

[adams]

thanx for your replies benjamin n consumer guy

how should i perform robustness studies.

varrying temp, pH, flow rate, wavelength,
mobile phase composition from my chromatographic conditions.

To how much degree n whats the acceptance criteria for obtained result by such varriation.


regards

Adam

[syx]

I think we can exclude the wavelength in HPLC robustness study. Variation can be done to mobile phase composition, pH change, buffer capacity, flow rate, temperature, and column type, brand, lot, or age.
The acceptance criteria are the system suitability should be passed. See USP general information chapter Validation of Compendial Methods <1225> - System Suitability.
Hope it helps.

[andy]

I believe that you should explore the effect of small wavelength changes on the robustness of an HPLC method. The USP sets the wavelength accuracy specification for UV detectors that the measured wavelength has to be within 3 nm of the set wavelength. This means that two different detectors could vary by as much as 6 nm in their actual wavelength. This could have a big effect on the response of any compound.

[adam]

Can you tell me where in the USP this information is located. I have always had trouble finding qualification specs in the USP.

Thanks

[andy]

It is in the general chapter on chromatography where they talk about HPLC.

[FARD]

Robustness study is to study the capability of method due to change in working parameters during it's normal use.

So by interpreting the results of robustness study w.r.t different parameters necessary precautionary conditions can be incorporated in the Standard analytical procedure to get the desired precison in the results. So acceptance criteria is based on the predetermined precision requirement depending on different tests.

It is desirable that the small deliberate changes in robustness study should not affect the results of test, indicating more efficient method when normally used.