Seamless Method Transfer and Migration Between Instruments: Replicating an Aspirin and Related Substances Method on an Arc HPLC System

Importance of the Topic

Reliable transfer and migration of analytical methods between different liquid chromatography systems is essential to maintain data integrity, ensure regulatory compliance and support efficient quality control across laboratories and contract organizations. Demonstrating equivalent performance on a modern HPLC platform removes the need for extensive method revalidation and streamlines laboratory operations.

Study Objectives and Overview

This work presents the migration of an official USP/Ph. Eur. method for assay of aspirin and its related substances from established Agilent and Waters systems onto a new Arc HPLC System. The goal was to confirm that the Arc system replicates chromatographic resolution, system suitability parameters and impurity assay results without modifying the original method conditions.

Methodology and Used Instrumentation

The study employed stock solutions of aspirin API (0.1 mg/mL) spiked with known impurities at 10 % levels and real tablet extracts (0.5 mg/mL). Chromatography used an XSelect HSS T3 column (4.6 × 150 mm, 3.5 µm) at 40 °C with a 60:40 water/acetonitrile mobile phase gradient (0.1 % formic acid) and 15 µL injections. System suitability and assay runs were performed in triplicate on:

• Agilent 1260 Infinity II LC with DAD detector
• Waters Alliance e2695 HPLC with PDA detector
• Arc HPLC System with PDA detector

Main Results and Discussion

The Arc HPLC System achieved baseline separation of aspirin and impurities with USP resolution ≥ 5.8, tailing factors of 1.1–1.2 and retention factors ≥ 2.0, matching the performance of comparison instruments. Relative retention times (RRT) for all impurities were within 1 % across systems, preserving peak identification criteria. System suitability tests met USP requirements (resolution NLT 2.0, RSD NMT 4 %) with the Arc system showing even lower RSD values. Assay of real tablet samples yielded salicylic acid levels below the USP limit of 3 % on all platforms.

Benefits and Practical Applications

• Seamless method transfer avoids revalidation, saving time and resources
• Ensures consistent, regulatory-compliant results across diverse laboratories
• Supports rapid adoption of modern instrumentation with minimal training
• Improves laboratory throughput and productivity

Future Trends and Opportunities

As laboratories adopt platform-agnostic approaches, robust method transfer will increasingly rely on digital tools, advanced data analytics and machine learning to predict and adjust for system-specific differences. Integration of automated method translation software and cloud-based data sharing will further accelerate global collaboration and standardization in pharmaceutical analysis.

Conclusion

The Arc HPLC System demonstrated equivalent chromatographic separation, system suitability and impurity assay performance to established Agilent and Waters platforms without altering the validated method. This confirms its suitability for routine testing, regulatory compliance and efficient method migration, reducing the burden of asset replacement in QC laboratories.

References

1. USP General Chapter 1224, Transfer of Analytical Procedures. United States Pharmacopeia USP 43–NF 38.
2. Ph. Eur. Monograph Acetylsalicylic Acid, European Pharmacopeia 10.0, 2017.
3. Maziarz M, Rainville P, Tran Pham, Development of a Robust Method for Analysis of Aspirin and Related Substances Using a Statistical Software and Quality-by-Design Approach, Waters Application Note 720007177EN, 2021.