USP method transfer on UHPLC is no more challenge for the analysis of Amoxicillin Oral Suspension

Significance of the Topic

Accurate and efficient analysis of amoxicillin in oral suspension is critical for quality control in pharmaceutical production and regulatory compliance. Transferring legacy USP HPLC methods to modern UHPLC platforms can dramatically improve throughput, resolution and sustainability by reducing run times, solvent and sample consumption.

Objectives and Study Overview

This study demonstrates the application of the Shimadzu Method Transfer program to convert the USP monograph method for amoxicillin oral suspension (USP41-NF36) from conventional HPLC to ultra-high performance liquid chromatography (UHPLC) using sub-2 µm column technology. The goal was to achieve comparable separation performance while significantly cutting analysis time and resource use.

Methodology and Instrumentation

Sample and standard preparations followed USP guidelines with a target concentration of 1 mg/mL. Method transfer was guided by column matching (USP L1 chemistry) and software-derived parameter scaling. System suitability checks (%RSD for peak area, USP tailing factor) were performed according to monograph criteria.

Used Instrumentation:

• Nexera UHPLC system
• LC-2030C HPLC system
• Shim Pack GIST AQ C18 column (4.6×250 mm, 5 µm)
• Shim Pack GISS C18 column (2.1×100 mm, 1.9 µm)
• UV detector at 230 nm
• Nylon syringe filter (0.22 µm)

Main Results and Discussion

The UHPLC method achieved baseline separation of amoxicillin with a run time of 3.0 minutes versus 20 minutes for HPLC. Retention times shifted from ~5.24 min (HPLC) to ~1.02 min (UHPLC). Both methods met USP system suitability: %RSD <0.2% and tailing factors <1.3 across five replicates. Solvent consumption decreased by 96% and analysis time by 85%.

Benefits and Practical Applications

Method transfer to UHPLC enhances laboratory throughput, reduces reagent and sample use, and lowers operating costs. Rapid turnaround and reduced environmental impact make this approach suitable for routine QC of generic amoxicillin formulations.

Future Trends and Applications

Wider adoption of UHPLC in pharmaceutical quality control is expected, with further miniaturization and automation. Method transfer tools will facilitate updating legacy methods across diverse drug monographs, promoting green analytical chemistry.

Conclusion

The USP HPLC method for amoxicillin oral suspension was successfully transferred to UHPLC using sub-2 µm column chemistry and Shimadzu software tools, achieving comparable separation quality with significant gains in speed, solvent savings and sustainability.

References

1. C190-E097 Shimadzu LC World Talk International Edition spring, 2006.
2. Thambavita D. et al., Journal of Pharmaceutical Sciences, vol. 106, 2017.
3. USP Monograph: Amoxicillin for Oral Suspension USP41-NF36, 2017.