Waters Arc HPLC

Significance of the Topic

High-performance liquid chromatography remains the cornerstone of quality control and regulatory compliance in pharmaceutical and industrial laboratories.

Objectives and Study Overview

This application note evaluates the Arc HPLC System for routine analysis, focusing on its ability to deliver high-efficiency separations, precise injections, low carryover, and seamless method transfer without revalidation.

Methodology

Multiple case studies demonstrate system performance: the United States Pharmacopeia assay for losartan potassium, impurity profiling of an active pharmaceutical ingredient, a high-speed separation compared with a binary HPLC system, and method scaling to smaller particle columns. Standard mobile phases, injection volumes, and flow rates were applied consistently to benchmark efficiency, precision, and resolution metrics.

Applied Instrumentation

• Arc HPLC System with quaternary pump and pressure tolerance up to 9500 psi
• Automated solvent degassing, seal wash, and fluidic design to minimize clogging
• Sample and column temperature control modules
• Photodiode array and UV/Vis detectors for high sensitivity and linearity
• Gradient SmartStart and Auto•Blend Plus for accurate gradient formation
• Compatibility with Empower Software for compliance-ready data integrity

Key Findings and Discussion

• Losartan assay met USP requirements: plate count >12000, tailing factor 1.0, injection precision RSD 0.10%
• Arc system matched or exceeded competitive HPLC platforms in efficiency, peak shape, and precision
• Method transfer from an Alliance system preserved retention times and impurity resolution without dwell volume adjustments
• Quaternary gradient achieves binary-like performance at high flow, delivering superior peak area repeatability
• Scaling to smaller particle columns improved resolution of critical peak pairs (Rs increased from 1.7 to 2.5) and reduced run time by over 30%

Benefits and Practical Applications

The Arc HPLC System streamlines method transfer and validation, reduces solvent consumption, enhances throughput, and minimizes downtime through robust fluidics and automated functions, making it well suited for high-volume quality control environments.

Future Trends and Opportunities

Advances in automated workflows, integration of artificial intelligence for method optimization, microfluidic HPLC platforms, and expanded applications in biopharmaceutical and complex matrix analysis will further enhance laboratory productivity and data quality.

Conclusion

The Arc HPLC System offers a reliable, high-pressure, and flexible platform that satisfies stringent assay requirements, simplifies method transfer, and improves laboratory efficiency while maintaining full compliance with regulatory standards.

References

• Waters Corporation. Arc HPLC System Application Note (720006940EN), 2020