i-Series Method Transfer System

Importance of the Topic

Liquid chromatography is a cornerstone technique for pharmaceutical and chemical analysis. Efficient method transfer between HPLC and UHPLC workflows accelerates development cycles, ensures consistent data quality, and optimizes laboratory resource utilization.

Objectives and Study Overview

This work introduces the Shimadzu i-Series Method Transfer (MT) system, designed to integrate conventional HPLC and high-speed UHPLC analyses on a single platform. It addresses inter-instrument variability caused by differences in system delay volumes and fulfills USP <621> compliance to minimize revalidation requirements.

Methodology and Instrumentation

The MT system features dual flow lines calibrated for HPLC and UHPLC delay volumes, allowing seamless method migration. A核心component is the Analytical Condition Transfer and Optimization (ACTO) function in LabSolutions software, which automatically adjusts gradient timing and injection schedules to compensate for volumetric differences. Other methodological highlights include controlled column heating up to 85 °C, sub-microliter injection precision, low carryover, and dual temperature control of the detector optics to stabilize baselines under varying ambient conditions.

Used Instrumentation

• Shimadzu i-Series Method Transfer System (MT system)
• LabSolutions software with ACTO functionality
• Shim-pack™ VP-ODS column (150 × 4.6 mm, 5 µm) for HPLC
• Shim-pack™ XR-ODS II column (75 × 3.0 mm, 2.2 µm) for UHPLC
• 10-port switching valve for flow line selection
• UV detector with dual temperature control cell

Main Results and Discussion

Dual flow-line operation yielded equivalent impurity profiles for ketoprofen under HPLC (12 min run) and UHPLC (2.5 min run) conditions. Activation of the ACTO function reduced retention time deviations from approximately 0.49 min to 0.04 min in sulfa drug analyses and from 0.25 min to 0.01 min for UV absorber mixtures, demonstrating robust reproducibility across different LC platforms.

Benefits and Practical Applications

• Effortless migration between HPLC and UHPLC methods without manual reprogramming.
• Compliance with USP <621> parameter tolerances to avoid full revalidation.
• Up to fivefold acceleration of analysis throughput for QA/QC workflows.
• Reduced laboratory footprint by combining two systems into one.
• Intuitive touch-panel interface for rapid flow line switching.

Future Trends and Opportunities

Emerging developments may include AI-driven method optimization, tighter integration with LC–MS platforms, and expanded connectivity within laboratory informatics. Advanced real-time transfer algorithms could further enhance cross-platform compatibility and streamline analytical workflows.

Conclusion

The Shimadzu i-Series MT system provides a unified, high-performance solution for HPLC and UHPLC analyses. Through its dual-flow design and ACTO-driven method transfer, it delivers superior reproducibility and significant time savings, meeting the evolving needs of pharmaceutical and industrial analytical laboratories.