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Bioanalysis of emixustat (ACU-4429) in whole blood collected with volumetric absorptive microsampling by LC-MS/MS.
Bioanalysis. 2015; 7(16):2071-83.B

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.

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Publisher Full Text

Authors+Show Affiliations

Miao Z
Covance Laboratories, Inc., 3301 Kinsman Blvd., Madison, WI 53704, USA.
Farnham JG
Covance Laboratories, Inc., 3301 Kinsman Blvd., Madison, WI 53704, USA.
Hanson G
Covance Laboratories, Inc., 3301 Kinsman Blvd., Madison, WI 53704, USA.
Podoll T
Acucela, Inc., 21720 23rd Drive SE, Suite 120, Bothell, WA 98021, USA.
Reid MJ
Acucela, Inc., 21720 23rd Drive SE, Suite 120, Bothell, WA 98021, USA.

MeSH

AnticoagulantsBlood Specimen CollectionCalibrationChromatography, LiquidDried Blood Spot TestingDrug StabilityFreezingHematocritHumansMalePhenyl EthersPropanolaminesReproducibility of ResultsSodium FluorideTandem Mass SpectrometryTemperature

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26327186

Citation

Miao, Zhixin, et al. "Bioanalysis of Emixustat (ACU-4429) in Whole Blood Collected With Volumetric Absorptive Microsampling By LC-MS/MS." Bioanalysis, vol. 7, no. 16, 2015, pp. 2071-83.
Miao Z, Farnham JG, Hanson G, et al. Bioanalysis of emixustat (ACU-4429) in whole blood collected with volumetric absorptive microsampling by LC-MS/MS. Bioanalysis. 2015;7(16):2071-83.
Miao, Z., Farnham, J. G., Hanson, G., Podoll, T., & Reid, M. J. (2015). Bioanalysis of emixustat (ACU-4429) in whole blood collected with volumetric absorptive microsampling by LC-MS/MS. Bioanalysis, 7(16), 2071-83. https://doi.org/10.4155/bio.15.125
Miao Z, et al. Bioanalysis of Emixustat (ACU-4429) in Whole Blood Collected With Volumetric Absorptive Microsampling By LC-MS/MS. Bioanalysis. 2015;7(16):2071-83. PubMed PMID: 26327186.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bioanalysis of emixustat (ACU-4429) in whole blood collected with volumetric absorptive microsampling by LC-MS/MS. AU - Miao,Zhixin, AU - Farnham,James G, AU - Hanson,Glenn, AU - Podoll,Terry, AU - Reid,Michael J, PY - 2015/9/2/entrez PY - 2015/9/4/pubmed PY - 2016/6/9/medline SP - 2071 EP - 83 JF - Bioanalysis JO - Bioanalysis VL - 7 IS - 16 N2 - 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. SN - 1757-6199 UR - https://www.unboundmedicine.com/medline/citation/26327186/Bioanalysis_of_emixustat__ACU_4429__in_whole_blood_collected_with_volumetric_absorptive_microsampling_by_LC_MS/MS_ L2 - https://www.future-science.com/doi/10.4155/bio.15.125?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -