Purity of 2-amino-N-(2,2,2- trifluoroethyl)-acetamide by ion chromatography

Significance of the Topic

Purity control of 2-amino-N-(2,2,2-trifluoroethyl)-acetamide is essential in pharmaceutical syntheses since impurities can compromise reactions, yields and product safety.

Objectives and Study Overview

This study aims to develop a rapid ion chromatography approach to quantify glycine, sodium, 2,2,2-trifluoroethylamine and inorganic cations in the target compound. The method ensures total impurity peak area remains under 2% relative to all detectable peaks over the reporting threshold.

Methodology and Instrumentation

• Column: Metrosep C4 - 250/4.0 with C4 Guard/4.0
• Eluent: 2.5 mmol/L nitric acid
• Flow rate: 1.5 mL/min; injection volume: 10 µL; recording time: 15 min; column temperature: 30 °C
• Detection: direct conductivity
• Sample preparation: none required

Used Instrumentation

• Metrohm 883 Basic IC plus
• Metrohm 863 Compact IC Autosampler

Main Results and Discussion

The target analyte exhibited a purity of 99.57%. Glycine and sodium impurities were detected at 0.14% and 0.29% respectively, while 2,2,2-trifluoroethylamine was not observed above the detection limit. The results demonstrate the method’s selectivity and sensitive quantification capabilities, meeting the stringent impurity criterion.

Benefits and Practical Applications

• No sample preparation simplifies workflow and reduces analysis time.
• High sensitivity and reproducibility support routine quality control in API production.
• Straightforward implementation on standard ion chromatography platforms.

Future Trends and Opportunities

Anticipated developments include coupling ion chromatography with mass spectrometry for enhanced analyte identification, method miniaturization, real-time process monitoring and adoption of greener eluents. Automation and data integration will further streamline pharmaceutical QC workflows.

Conclusion

The described ion chromatography method offers a robust, accurate and efficient solution for purity assessment of 2-amino-N-(2,2,2-trifluoroethyl)-acetamide. It ensures compliance with impurity limits and can be readily integrated into pharmaceutical quality assurance protocols.

References

• Application Note C–175, Metrohm