Expedient Method Transfer of a UPLC Method for Budesonide Nasal Spray Using ACQUITY UPLC H-Class PLUS Binary and ACQUITY UPLC Systems

Importance of Topic

This study addresses the analytic challenge of transferring a validated isocratic UPLC method for budesonide nasal spray between two Waters chromatography platforms. Reliable method transfer is critical for quality-controlled laboratories to ensure consistent results across instruments and improve throughput.

Objectives and Overview of Study

The primary aim was to demonstrate method equivalency between the ACQUITY UPLC H-Class PLUS Binary System and the standard ACQUITY UPLC System using the USP budesonide method. Performance metrics were compared for resolution, retention time, plate count, and relative retention time.

Methodology and Instrumentation

• Samples and Standards: Budesonide analytical standard (12.8 µg/mL) and Benacort® nasal spray prepared per USP guidelines.
• Chromatography Systems: ACQUITY UPLC System with Binary Solvent Manager (BSM) and ACQUITY UPLC H-Class PLUS Binary System with BSM and Sample Manager FTN.
• Columns: Waters ACQUITY UPLC BEH C18, 1.7 µm, 2.1 × 50 mm (two different lot numbers).
• Injection Protocol: Six replicate injections of sample and standard on each system under isocratic conditions from the USP monograph.

Main Results and Discussion

• Resolution between epimers consistently 1.9, exceeding USP requirement of ≥1.5 on both systems.
• Plate counts for epimer B around 9000–9900, above USP threshold of ≥5500; a ∼10 % increase on the H-Class PLUS attributed to a fresh column.
• Retention time variation under 0.1 min between platforms, demonstrating negligible impact of dwell volume on isocratic analyses.
• Relative retention times matched to one decimal place across systems, confirming transfer fidelity.

Benefits and Practical Applications

• Validated method transfer ensures consistent QC of budesonide nasal spray across different UPLC platforms.
• Enhanced robustness and throughput support routine laboratory operations.
• Facilitates compliance with pharmacopeial criteria in regulated environments.

Future Trends and Applications

The success of this isocratic transfer paves the way for more complex gradient-based peptide mapping and profiling applications using the H-Class PLUS Binary System. Laboratories may leverage its dynamic gradient capabilities and high-pressure mixing for advanced method development and high-throughput quality assessment of diverse analytes.

Conclusion

The ACQUITY UPLC H-Class PLUS Binary System demonstrated equivalent or improved performance compared to the standard ACQUITY UPLC System for USP budesonide analysis. All system suitability criteria were met, confirming a robust, transferable method for routine analytical use.

Reference

1. Henry, C.; Rainville, P. Assessment of the System Performance of the Waters ACQUITY UPLC H-Class PLUS Binary System. Waters Application Note, 720006649EN, 2019.
2. Chavali, A.; Jenkins, T.; McConville, P. USP Method Transfer and Routine Use Analysis of Budesonide Nasal Spray from HPLC to UPLC. Waters Application Note, 720004129EN, 2013.
3. USP Monograph Budesonide, USP34-NF29, 2083. The United States Pharmacopeial Convention, official from May 1, 2011.