Validation of a liquid chromatography-triple quadrupole mass spectrometric method for the determination of 5-nitro-5-hydroxy-indirubin-3-oxime (AGM-130) in human plasma and its application to microdose clinical trial
- Authors
- Park, Min-Ho; Lee, Yun Young; Cho, Kyung Hee; La, Sookie; Lee, Hee Joo; Yim, Dong-Seok; Ban, Sooho; Park, Moon-Young; Kim, Yong-Chul; Kim, Yoon-Gyoon; Shin, Young G.
- Issue Date
- Mar-2016
- Publisher
- WILEY-BLACKWELL
- Keywords
- AGM-130; cyclin-dependent kinase (CDK) inhibitor; liquid-liquid extraction; LC-MS; MS; microdose clinical trial
- Citation
- BIOMEDICAL CHROMATOGRAPHY, v.30, no.3, pp 323 - 329
- Pages
- 7
- Journal Title
- BIOMEDICAL CHROMATOGRAPHY
- Volume
- 30
- Number
- 3
- Start Page
- 323
- End Page
- 329
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/64301
- DOI
- 10.1002/bmc.3551
- ISSN
- 0269-3879
1099-0801
- Abstract
- A liquid chromatography-triple quadrupole mass spectrometric (LC-MS/MS) method was developed and validated for the determination of 5-nitro-5-hydroxy-indirubin-3-oxime (AGM-130) in human plasma to support a microdose clinical trial. The method consisted of a liquid-liquid extraction for sample preparation and LC-MS/MS analysis in the positive ion mode using TurboIonSpray(TM) for analysis. d(3)-AGM-130 was used as the internal standard. A linear regression (weighted 1/concentration) was used to fit calibration curves over the concentration range of 10-2000 pg/mL for AGM-130. There were no endogenous interference components in the blank human plasma tested. The accuracy at the lower limit of quantitation was 96.6% with a precision (coefficient of variation, CV) of 4.4%. For quality control samples at 30, 160 and 1600 pg/mL, the between run CV was 5.0 %. Between-run accuracy ranged from 98.1 to 101.0%. AGM-130 was stable in 50% acetonitrile for 168 h at 4 degrees C and 6 h at room temperature. AGM-130 was also stable in human plasma at room temperature for 6 h and through three freeze-thaw cycles. The variability of selected samples for the incurred sample reanalysis was 12.7% when compared with the original sample concentrations. This validated LC-MS/MS method for determination of AGM-130 was used to support a phase 0 microdose clinical trial. Copyright (c) 2015 John Wiley & Sons, Ltd.
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