[brbabu_1979]

Hi every one, I have one doubt about method validation. If you have three dosage forums (like 10 mg/ml, 15 mg/ml and 20 ml/mg), at the time of analytical method validation by HPLC which form we should select for the validation? Why? Are there any recommendation guidelines for this? Please explain me. Thanks in advance.

Babu

[Train]

It depends on which validation parameter you are looking at and if there are any significant differences in formulation and/or sample prep.  If they are in the same matrix (e.g. no difference in levels of preservatives, etc.) and the only difference in sample prep is different dilution schemes, then you should be able to justify picking one as representative of all three.

[brbabu_1979]

Thanks Train for your replay. In my sample matrix has no differences in preservatives and excipients, only difference in active drug only. Ours is oral suspension. Are there any guidelines suggests to select particular dosage form to do the validation. I know that if we select the high dosage form and prove the linearity calibration curve, I hope that is enough. If any auditor ask why do you select particular dosage form we have to tell them as per ..this guidelines. That's why I am asking this.

[Lisa]

Hi
It depends on what stage you are validating the method to support.

For Phase 1, there are no set-in-stone recovery guidelines, most people use accuracy and linearity .  I would just bracket your dose and perform three replicates of each to show recovery.  Of course, if you use validation as time zero of a stability study, you would run all three.

For Phase 3, (which I don't do very often), you do need to show recovery (including spiked recovery) at least at all three levels.  You may also have to extend that range to 80-120% of the known doses.