What is minimum number of replicate injection or determination that given to the system (HPLC or HPTLC) for each condition in a robustness study as per ICH....guideline.....?
Dear Sir. Concerning your issue about the minimum number of replicate injection or determination that given to the system (HPLC or HPTLC) for each condition in a robustness study as per ICH guideline. The number of replicate injection or determination sholud be at least three replicates. The following attached files may help you in your analysis
Thanks
The robustness test examines the potential sources of variability in one or a number of responses of the method.
Fallowing parameters need to study as per ICH
pH in a mobile phase
Mobile phase composition
Different columns (different lots and/or suppliers)
Temperature
Flow rate
We need to change ±2% to ±5 based on the condition. we need to do triplet analysis for all the changes
Three replicates at the least in all the conditions would be a good indicator to comment on the robustness of the method.
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