Parameter Set Mycophenolic Acid - LC-MS/MS

Order No.: 92916
Parameters:
Mycophenolic Acid, Mycophenolic Acid Glucuronide

For the analysis of MPA and MPAG
3PLUS1® and 6PLUS1® Multilevel Calibrator Sets available
Part of the MassTox® TDM Series A
Method for automated sample preparation also available

CE-IVD validated product ready for IVDR within timeframes and transition periods specified by the IVDR-2022 regulation

Mycophenolic Acid

Mycophenolic Acid Glucuronide

Clinical relevance

Mycophenolic acid (MPA) is used as an immunosuppressant agent to prevent organ transplant rejection. MPA selectively inhibits the synthesis of purines and specifically reduces the growth of B- and T-lymphocytes. Furthermore, MPA is also used to treat autoimmune diseases such as psoriasis, systemic lupus erythematosus or scleroderma.

Therapeutic monitoring of MPA in the blood is required to adjust individual concentrations within the therapeutic window and to attain a favourable ratio between therapeutic effects and side effects. Currently available drugs contain mycophenolate mofetil or mycophenolate sodium, which are both completely metabolised into the active metabolite MPA. For excretion, MPA is bound to glucuronic acid. As this step is reversible, it is advisable to analyse MPA glucuronide (MPAG) in serum/plasma, too.

 

Product advantages

With the Parameter Set Mycophenolic Acid in serum/plasma, MPA and its metabolite MPAG can be measured fast and efficiently using LC-MS/MS. Due to the careful optimisation of all kit components as well as the chromatographic separation, matrix effects (“ion suppression”) is minimised and the robustness of the method is enhanced. Sample preparation is based on a protein precipitation step. The use of deuterated internal standards allows this method to produce reproducible results despite the presence of in-source fragmenting, which is characteristic of this substance. The use of 3PLUS1® or 6PLUS1® multilevel calibrators guarantees high precision and reliable quantification. The method is comprehensively validated.

The Parameter Set is a part of the Series A modular system, which enables the analysis of all parameters without switching column or changing the mobile phases, thereby minimising required workload in the laboratory. The Basic Kit A contains all components required for sample preparation and all necessary mobile phases. The MasterColumn® A is the analytical column used for the determination of all Series A analytes. Our portfolio contains further MassTox® Parameter Sets.

For the analysis you require the MassTox® TDM Basic Kit A, the specific MassTox® TDM Parameter Set and the analytical column MassTox® TDM MasterColumn® A.

More Information
Method of Analysis LC-MS/MS
Limit of quantification

MPA < 0.1 mg/l, MPAG < 0.5 mg/l

Linearity

MPA up to 20 mg/l, MPAG up to 500 mg/l

Recovery 105 – 119 %
Intraassay CV < 4 %
Interassay CV < 5.5 %
Analysis Time 1.5 min
Specimen Serum/Plasma
Sample Preparation
  • Reconstitute the Internal Standard Mix
  • Add 800 μl Internal Standard mix to 12 ml Precipitation Reagent to form mixture A
  • Pipette 50 μl sample/calibrator/MassCheck® control into a 1.5 ml reaction vial
  • Add 25 μl Extraction Buffer, mix briefly (vortex) and incubate 2 min.
  • Add 250 μl of mixture A and mix 30 s minimum (vortex) and centrifuge 5 min.
  • Dilute the supernatant with Dilution Buffer prior to injection depending on the instrument sensitivity
Sample Stability Samples are stable up to 4 weeks at +2 to +8 °C. For longer storage periods keep samples frozen below -18 °C.
Injection Volume 0.2 – 50 µl
Gradient

Starting point: 60 % Mobile Phase 2
0.00→0.50 min  100 % Mobile Phase 2
0.51–1.00 min    100 % Mobile Phase 2
1.01→1.10 min    60 % Mobile Phase 2
1.11–1.81 min      60 % Mobile Phase 2

Ionisation ESI positive
MS/MS-Mode MRM
Additional Info We recommend to set the scan time to a value that allows to achieve a minimum of 10 data points over the whole peak width.
Please note The freely available information on this website, in particular on the sample preparation, are not sufficient to work with our products. Please read instructions and warning notices on products and/or instruction manuals.
Parameter Mycophenolic Acid, Mycophenolic Acid Glucuronide
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