Bioanalysis of emixustat (ACU-4429) in whole blood collected with volumetric absorptive microsampling by LC-MS/MS.
BACKGROUND
A method to quantify emixustat (an investigational drug agent) in human blood collected using volumetric absorptive microsampling (VAMS) could be more practical for sample collection at sites with limited facilities for processing and storage of plasma.


METHODS
A LC-MS/MS method was developed and evaluated for accuracy and precision, linearity, carryover, selectivity, recovery, matrix effects, hematocrit effects and stability.


RESULTS
Core validation parameters met acceptance criteria within the normal ranges of hematocrit levels for adults (30-55%). Stability of emixustat in blood collected with and without anticoagulant (NaF/KOx) on the VAMS device at ambient, refrigerated and frozen conditions was established.


CONCLUSIONS
The method has been validated and is suitable for the bioanalysis of emixustat in human blood collected by VAMS.
Covance Laboratories, Inc., 3301 Kinsman Blvd., Madison, WI 53704, USA.
Zhixin
Z
Miao
Covance Laboratories, Inc., 3301 Kinsman Blvd., Madison, WI 53704, USA.
James G
JG
Farnham
Covance Laboratories, Inc., 3301 Kinsman Blvd., Madison, WI 53704, USA.
Glenn
G
Hanson
Acucela, Inc., 21720 23rd Drive SE, Suite 120, Bothell, WA 98021, USA.
Terry
T
Podoll
Acucela, Inc., 21720 23rd Drive SE, Suite 120, Bothell, WA 98021, USA.
Michael J
MJ
Reid
D000925:Anticoagulants / Q000737:chemistry; D001800:Blood Specimen Collection / Q000379:methods*; D002138:Calibration; D002853:Chromatography, Liquid / Q000379:methods*; D059788:Dried Blood Spot Testing / Q000379:methods; D004355:Drug Stability; D005615:Freezing; D006400:Hematocrit; D006801:Humans; D008297:Male; D010647:Phenyl Ethers / Q000097:blood*; D011412:Propanolamines / Q000097:blood*; D015203:Reproducibility of Results; D012969:Sodium Fluoride / Q000737:chemistry; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013696:Temperature
D000925:Anticoagulants; D010647:Phenyl Ethers; D011412:Propanolamines; C000592692:emixustat; D012969:Sodium Fluoride