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AN64047-EN 1014S

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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.pdf

3. 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.

ISO 13485