A sensitive assay for ZYAN1 in human whole blood and urine utilizing positive LC-MS/MS electrospray ionization

被引:1
|
作者
Patel, Harilal [1 ]
Soni, Krunal [1 ]
Trivedi, Rucha [1 ]
Heading, Heather [2 ]
Geue, Jason [2 ]
Kansagra, Kevinkumar [3 ]
Gupta, Rahul J. [3 ]
Pandya, Vrajesh B. [4 ]
Srinivas, Nuggehally R. [1 ]
Patel, Pankaj R. [1 ,3 ,4 ]
Desai, Ranjit C. [4 ]
机构
[1] Zydus Res Ctr, Bioanalyt Lab, Ahmadabad 382210, Gujarat, India
[2] CPR Pharma Serv, Thebarton, SA 5031, Australia
[3] Zydus Res Ctr, Clin Res, Ahmadabad 382210, Gujarat, India
[4] Zydus Res Ctr, Med Chem, Ahmadabad 382210, Gujarat, India
关键词
anemia; LC-MS/MS; method validation; pharmacokinetics; prolyl hydroxylase inhibitors; whole blood; ZYAN1; PROLYL HYDROXYLASE INHIBITOR; ROXADUSTAT FG-4592; ANEMIA; HYPOXIA; DISEASE; ALPHA;
D O I
10.4155/bio-2017-0014
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
Aim: A sensitive LC-MS/MS method was developed and validated for estimation of ZYAN1 in human blood/urine. Methods: An analog internal standard IOX2 along with ZYAN1 was quantified using selective reaction monitoring in positive mode. The chromatographic separation was performed by gradient elution with C-18 analytical column (3 mu m, 50 mm x 2.0 mm) with 4-min run time using an acidified mobile phase consisting of ammonium formate and acetonitrile. Protein precipitation enabled extraction of analytes from diluted blood/urine. Results: Calibration curve of ZYAN1 was linear (2-5000 ng/ml). The recovery of ZYAN1 and IOX2 was between 87 and 104%. Interday and intraday accuracy and precision was found well within the acceptance criteria. Conclusion: The validated assay was applied for clinical pharmacokinetics of ZYAN1 in healthy volunteers.
引用
收藏
页码:719 / 732
页数:14
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