I am getting recovery of a drug from plasma about 50% compare to water which is analysed by HPLC and getting lower concentrations detected nicely.... Is the mathod valid or acceptable?
I would call this not acceptable. The drug could be to tightly bound too some plasma protein or the conditions (like pH) are too much different between the aqeous solution and plasma workup.
What is also interesting, do you obtain the same recovery from plasma in every experiment, with a high reproducebility?
I would recommend a maximum difference in recovery of 5-10% and results should be highly reproducible.
Dear Urvesh,
You may refer to FDA Bioanalytical Method Validation guidance (May 2018): „The sponsor should optimize the recovery of the analyte to ensure that the extraction is efficient and reproducible. Recovery need not be 100 percent, but the extent of the recovery of an analyte and of the ISs should be consistent and reproducible.” Summing up, if the recovery is constant across your calibration range (within +/- 15%), then your method will produce reliable results.
Best regards,
Piotr
Dear patel,
same time it is acceptable but in recent past recovery should be between the extracted and post extracted. we should compare the extracted recovery with post extracted samples.for more details refer (what is post extracted) from FDA guidence for industry for bioanaltyical mehods. or can u call me at 8790807587 after 8.30 PM
Best Regards,
Madhusudhan.
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