Out-of-the-box usability of Thermo Scientific UltiMate 3000 and Vanquish Core HPLC instruments for the compendial analysis of commonly prescribed drugs

Importance of the Topic

High-performance liquid chromatography remains a cornerstone in pharmaceutical quality control, offering precise measurement of drug content and impurities. Millions of prescriptions for chronic treatments rely on validated compendial assays. Ensuring new instrument platforms can seamlessly support legacy United States and European Pharmacopeia methods is critical for regulatory compliance and effective lab workflows.

Study Objectives and Overview

This work evaluated two generations of Thermo Scientific HPLC systems—the UltiMate 3000 SD and the Vanquish Core—for direct implementation of nine pharmacopeial assays covering commonly prescribed drugs: lisinopril, amlodipine, metoprolol, losartan, levothyroxine, gabapentin, furosemide, hydrochlorothiazide, and omeprazole. Methods were sourced from USP and EP monographs to demonstrate instrument compatibility with official workflows. Key performance indicators included system suitability criteria, assay precision, resolution of critical impurity peaks, and method robustness during transfer.

Instrumentation

• UltiMate 3000 SD system: quaternary pump, autosampler, column compartment, diode array detector, solvent rack and monitor.
• Vanquish Core system: quaternary pump, split sampler, column compartment, diode array detector, solvent monitor.
• Standard HPLC columns and consumables from Thermo Scientific including Hypersil GOLD and BetaSil cyano phases.
• General laboratory equipment: vortex mixer, pH meter, single channel pipettes, autosampler vials, ultrapure water system.

Main Results and Discussion

• All monograph assays met or exceeded system suitability criteria on both platforms, with resolution and signal-to-noise within specified limits.
• Precision for quantification of active pharmaceutical ingredients and related substances showed relative standard deviations below pharmacopeial thresholds for both instruments.
• The singular exception was furosemide assay area precision on the UltiMate 3000, which marginally exceeded its specification while remaining acceptable on the Vanquish Core.
• Performance parameters such as retention time repeatability, peak symmetry, and theoretical plates demonstrated equivalent or improved chromatographic quality on the Vanquish Core compared to the UltiMate 3000 SD.

Benefits and Practical Applications

• Single-sourcing of equipment and consumables simplifies procurement and ensures consistent method performance.
• Direct compatibility with compendial monographs reduces method transfer effort and training time.
• Enhanced usability and automated features of the Vanquish Core system deliver reliable, worry-free operation for routine pharmacopeial assays.

Future Trends and Potential Applications

• Continued harmonization and modernization of pharmacopeial methods will drive adoption of advanced instrument platforms capable of supporting legacy workflows.
• Integration with data analytics and digital lab management will enhance method lifecycle management and regulatory compliance.
• Expansion of applications to emerging drug modalities and complex impurity profiling using hyphenated techniques such as LC-MS is anticipated.

Conclusion

Both the Thermo Scientific UltiMate 3000 SD and Vanquish Core HPLC systems deliver robust performance for pharmacopeial assays of widely prescribed drugs. The Vanquish Core offers comparable or improved chromatographic metrics and ease of use, facilitating method transfer and routine quality control in pharmaceutical laboratories.

References

1. Agency for Healthcare Research and Quality Data Tools 2019
2. Arzneiverordnungs-Report 2021 W. Ludwig and B. Muhlbauer
3. European Pharmacopeia monograph for lisinopril dihydrate 10.1
4. USP Monograph Amlodipine Besylate 2020
5. USP Monograph Metoprolol Tartrate 2020
6. USP Monograph Losartan Potassium 2022
7. USP Monograph Levothyroxine Sodium 2020
8. USP Monograph Gabapentin 2022
9. USP Monograph Furosemide 2020
10. European Pharmacopeia monograph Hydrochlorothiazide 10.0
11. USP Monograph Omeprazole 2020