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Application Note 612
References
1. Kuypers, D.R.; Le Meur, Y.; Cantarovich, M.,
et al.
Consensus report on therapeutic drug monitoring
of mycophenolic acid in solid organ transplantation.
Clinical Journal of the American Society of
Nephrology
: CJASN 2010;5:341-58.
2. COMMISSION DECISION of 12 August 2002
implementing Council Directive 96/23/EC concerning
the performance of analytical methods and the
interpretation of results. Official Journal of the
European Communities. L 221/8. 17.8.2002.
http://faolex.fao.org/docs/pdf/eur49615.pdf3. U.S. Food and Drug Administration, Guidance for
Industry, Bioanalytical Method Validation 2001.
(http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM070107.pdf).
Figure 1 presents a chromatogram showing the three
SRM scans. MPA and MPAG peaks are separated by
a retention time (RT) difference of approximately
0.6 minutes on the scan for the [M+H]
+
ion of MPA.
For quantitative analysis of the metabolite, maximum
conversion of MPAG to MPA is driven by optimizing
the severity of the ionization process.
The calibration curve was linear from 0.2 mg/L to
40 mg/L. Precision data is presented in Table 4 showing
CVs of 5.8–6.4% across the calibration range of the assay.
Conclusion
The research method developed using TurboFlow
technology allowed an accurate detection and
quantification of MPA. It is also fast, requires minimal
manual sample preparation, and conforms to current
guidelines.
Table 4. Interday precision study for LC-MS/MS analysis of MPA.
Four levels of quality control material, 10 replicates per level,
repeated over 5 consecutive days.
QC1
QC2
QC3
QC4
MEAN mg/L
1.7
6.9
11.3
33.5
STD DEV
0.1
0.4
0.7
1.9
CV%
6.4
6.3
6.2
5.8
Figure 1. Extracted ion chromatograms for MPA (top), MPAG (middle), and internal standard (bottom)
For research use only. Not for use in diagnostic procedures.
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