Bioanalysis of emixustat (ACU-4429) in whole blood collected with volumetric absorptive microsampling by LC–MS/MS

Author:

Miao Zhixin1,Farnham James G1,Hanson Glenn1,Podoll Terry2,Reid Michael J2

Affiliation:

1. Covance Laboratories, Inc., 3301 Kinsman Blvd., Madison, WI 53704, USA

2. Acucela, Inc., 21720 23rd Drive SE, Suite 120, Bothell, WA 98021, USA

Abstract

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. Conclusion: The method has been validated and is suitable for the bioanalysis of emixustat in human blood collected by VAMS.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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