LC-MS/MS Method of Fingolimod in Human Whole Blood: Is Sensitivity and Required Blood Volume an Issue?
PRESENTED TO: BioPharma Services Inc.
PRESENTED BY: J. PATEL
PURPOSE
LC-MS/MS Method of Fingolimod in Human Whole Blood: Is Sensitivity and Required Blood Volume an Issue? – The current LC-MS/MS method outline the process for highly sensitive assay of fingolimod from human whole blood in K2-EDTA.
Currently available methods within the industry are sensitive enough to achieve the LLOQ of 50 pg/mL only, using high sample
volume ranges between 0.7mL to 1mL, which leads to high volume of blood drawn from the volunteers during clinical trials. Our method has been successfully developed to achieve a high sensitivity at 5pg/mL and using 0.35mL sample volume only. Selectivity, matrix factor, matrix effect, recovery, robustness and stabilities were evaluated during vigorous approach of validation.
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