Bioequivalence and Bioavailability Forum 13:19 CET

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Resolution value in BE studies [Bioanalytics]

posted by sera - 2019-01-02 13:30  - Posting: # 19721
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Dear Members,

In BE studies, what are the acceptance criteria for the resolution value for analytical procedure of analyte of interest and internal standard? A resolution value >2 between the peak of interest and internal standard is desirable in analytical method validation but there are no acceptance criteria about resolution value in EMA and FDA bioanalytical method validation guidelines.

In a completed HPLC study, the resolution value was about 1.2 during the study. Analyte and internal standard peaks were free of distortions and splitting. Internal standard behaved as the analyte at the every stage of the analysis. IS response variation was monitored in each batch regularly. No problem was observed between spiked samples and study samples. Full validation was performed prior to analysis of study samples and the parameters were successfully validated.
During analysis of study samples; QC samples were within acceptance limits. ISR was performed and the results were acceptable.

How can the resolution value between analyte of interest and internal standard in the chromatograms for the above study be justified to be appropriate? What is your opinion for the baseline resolution lower limit?

Thanks in advance.

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