Analysis of Budesonide

Significance of the Topic

Analysis of budesonide and its epimer is crucial in pharmaceutical quality control for ensuring correct dosage and purity of corticosteroid formulations. Reliable separation of stereoisomers supports efficacy and safety in respiratory therapies.

Study Objectives and Overview

The application note demonstrates a reversed phase liquid chromatography method using a polar endcapped C18 column for baseline separation of budesonide and its epimer. Key goals include method robustness, reproducibility, and suitability for routine analysis.

Methodology and Instrumentation

• Liquid chromatography system Nexera XR
• Column Shim pack GISS C18 150 mm x 4.6 mm id 3 micron
• Mobile phases
  • Phase A phosphate buffer pH 3.2 acetonitrile ethanol in ratio 34 16 1
  • Phase B phosphate buffer pH 3.2 and acetonitrile 1 to 1
• Gradient program 0 to 38 minutes 0 percent B 38 to 50 minutes linear to 100 percent B hold to 60 minutes
• Flow rate 1.0 mL per minute
• Column temperature 50 degrees Celsius
• Injection volume 20 microliters
• Detection UV at 240 nm standard flow cell

Main Results and Discussion

The chromatogram shows two well resolved peaks corresponding to budesonide and its epimer with retention times around 15 and 18 minutes. The method delivers sharp peaks and adequate resolution making it suitable for routine monitoring. The polar endcapped surface of the stationary phase enhances peak symmetry and repeatability.

Benefits and Practical Applications

• High resolution separation of structurally similar steroid isomers
• Reproducible performance under typical QC conditions
• Compatibility with standard UV detection for cost effective analysis
• Applicability to assay validation and stability studies in drug development

Future Trends and Potential Applications

Anticipated advances include adopting ultrahigh pressure LC to reduce run times and solvent consumption. Coupling with mass spectrometry can enhance specificity for metabolite profiling. Development of greener mobile phases and automated sample handling will further streamline steroid analysis.

Conclusion

The presented reversed phase method using polar endcapped C18 column provides reliable separation of budesonide and its epimer. Its robust performance supports critical quality control applications in pharmaceutical analysis.

References

• Application News 01-00190 JP Shimadzu Corporation 2021 ERAS-1000-0205