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ACQUITY UPLC I-Class/Xevo TQD IVD System: Analytical Performance for Immunosuppressive Agents

ACQUITY UPLC I-Class/Xevo TQD IVD System: Analytical Performance for Immunosuppressive Agents
  • Waters Corporation
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For in vitro diagnostic use. Not available in all countries.

Introduction

The Waters ACQUITY UPLC I-Class/Xevo TQD IVD System enables the quantification of organic compounds in human biological liquid matrices.

This document describes a test of the analytical performance of the ACQUITY UPLC I-Class/Xevo TQD IVD System for the analysis of cyclosporine, everolimus, sirolimus, and tacrolimus in whole blood.

Experimental

The ACQUITY UPLC I-Class/Xevo TQD IVD System was controlled by MassLynx IVD (v4.1) and the data processed using the TargetLynx Application Manager. Whole blood Calibrators and Quality Controls were processed using the following conditions:

ACQUITY UPLC I-Class/Xevo TQD IVD System
ACQUITY UPLC I-Class/Xevo TQD IVD System.

Sample Preparation Conditions

50 μL sample was processed with aqueous zinc sulphate, acetonitrile, and centrifuged. Each analyte was analyzed individually.

LC Conditions

Column:

ACQUITY UPLC HSS C18 SB 1.8 μm, 2.1 mm x 30 mm

Mobile phase A:

2 mM Ammonium acetate+0.1% formic acid in water

Mobile phase B:

2 mM Ammonium acetate+0.1% formic acid in methanol

Flow rate:

0.4 mL/min

Gradient:

50% B for 0.2 minutes, 50–100% B over 0.4 minutes, hold 100% B for 0.6 minutes, equilibrate with 50% B for 0.6 minutes at 0.6 mL/min

MS Conditions

Resolution:

MS1 (0.75 FWHM), MS2 (1.2 FWHM)

Acquisition mode:

MRM

Polarity:

ESI (+)

Results and Discussion

Performance characteristics of cyclosporine, everolimus, sirolimus, and tacrolimus on the ACQUITY UPLC I-Class/Xevo TQD IVD System are shown in Table 1. Analytical sensitivity of the system is illustrated in Figure 1.

Performance characteristics of cyclosporine, everolimus, sirolimus, and tacrolimus
Table 1. Performance characteristics of cyclosporine, everolimus, sirolimus, and tacrolimus. Range defined by linear fit where r2 >0.99. LLOQ defined by S/N (PtP) >10  and %RSD ≤20%. % RSD at LLOQ determined through analytical sensitivity experiments performed over five occasions (n=50). Total precision and repeatability of  QCs performed over five occasions in whole blood (n=25). EQA mean bias determined by comparison of obtained values to the LC-MS all laboratories trimmed mean  (LC-MS ALTM) value (n=33). Note: The EQA mean bias for everolimus (-11.9%) is based on the returned EQA results for just two laboratories.
Chromatogram showing the analysis of 25 ng/mL cyclosporine and 1 ng/mL everolimus, sirolimus, and tacrolimus using the ACQUITY UPLC I-Class/Xevo TQD IVD System
Figure 1. Chromatogram showing the analysis of 25 ng/mL cyclosporine and 1 ng/mL everolimus, sirolimus, and tacrolimus using the ACQUITY UPLC I-Class/Xevo TQD IVD System.

Conclusion

The Waters ACQUITY UPLC I-Class/Xevo TQD IVD System has demonstrated the capability to deliver analytical sensitivity, accuracy, and precision for the analysis of cyclosporine, everolimus, sirolimus, and tacrolimus in whole blood.

Disclaimer

The analytical performance data presented here is for illustrative purposes only. Waters does not recommend or suggest analysis of the analytes described herein. These data are intended solely to demonstrate the performance capabilities of the system for analytes representative of those commonly analyzed using liquid chromatography and tandem mass spectrometry. Performance in an individual laboratory may differ due to a number of factors, including laboratory methods, materials used, intra-operator technique, and system conditions. This document does not constitute a warranty of merchantability or fitness for any particular purpose, express or implied, including for the testing of the analytes in this analysis.

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