AI-64310-CRFT

Thermo Scienti c Poster Note

•

PN63780_E 03/13S

Conclusion

Far too often LC/MS methods and instru

criteria Clinical Research Labs require fo

samples being injected on the system an

processed tax the instrumentation and c

developed proved a valuable whole-syst

consistent performance of the Prelude S

purpose-designed testing facilitates the i

standards for LC-MS systems used for cl

system suitability test allows vendors an

performance under controlled conditions

circumstances and has proven to be a va

to installation of Prelude SPLC Systems.

calibration and QC results for ISDs that

operating conditions at two different clini

Acknowledgements

The authors thank the following who host

Dr. William Clarke & Autumn Breaud of J

Dr. Mark Kellogg & Dr Roy Peake of Bost

Dr. Sihe Wang & Jessica Gabler of the Cl

ance

criteria would be the best

mmon problems with

est has four compounds

te problems that might exist

tention time and peak

detect any problems that

as their RT shifts with

ly susceptible to

h or made precisely as

powerful diagnostic tool.

all four compounds to

or less with no internal

re 8 shows typical

MassCheck is a trade mark of ChromSystems Instru

All other trademarks are the property of Thermo Fishe

This information is not intended to encourage use of t

intellectual property rights of others.

e Prelude SPLC System

FIGURE 10. Quantitative Results Imm

System was Suitable for well-known Clinical Research Methods

In order to asses the scope of applications for the Prelude SPLC system, popular LC-

MS methods used in clinical research were considered. Methods for steroids, pain

management drugs, immunosuppressant drugs and 25-OH-Vitamin D2 and D3, were

developed and evaluated. We monitored linearity within the experimental range, inter-

and intra-day reproducibility, long-term system stability, solvent consumption as

compared to other platforms, and other relevant parameters. Please see other posters

for more details on some of these methods. Figure 9 shows typical quantitative results

for the Vitamin D compounds - excellent reproducibility for peak areas and retention

times while achieving the desired sensitivity and linearity.

Even for Immunosuppressant Drug applications

Measuring Everolimus, Sirolimus, Tacrolimus and Cyclosporin A in whole-blood

samples presents many challenges, from sample preparation to detection of each

analyte and internal standard by the MS/MS system. To evaluate the Prelude SPLC

system’s ability to handle such an application, ChromSystems® multilevel calibrators

and MassCheck® whole blood controls were processed using D

-Cyclosporin A

(Alsachim, Illkirch-Graffenstaden, France) as the internal standard (IS) for Cyclosporin

A and Tacrolimus-

(Toronto Research Chemicals, Canada) as the IS for

Everolimus, Sirolimus and Tacrolimus. Typical RSDs of peak areas for the two IS

compounds were less than 12%.Typical quantitative results, collected over a span of

30 days from three systems in different locations - Cleveland, Baltimore and Boston,

are shown in Figure 9.

tention Time %CVs from 3

otype systems.

FIGURE 9. Quantitative Results – 25-OH-Vitamin D2 and D3