Analysis of Cetirizine Hydrochloride Using a Core Enhanced Technology Accucore HPLC Column

Importance of Topic

Cetirizine hydrochloride is a widely used antihistamine for allergy and hay fever treatment. Reliable and rapid analysis is essential in pharmaceutical quality control. Conventional USP methods employ strong acids, which can damage chromatography equipment and result in longer run times.

Objectives and Study Overview

This study evaluates the performance of a Thermo Scientific Accucore HILIC 2.6 µm column as an alternative to the USP monograph method. The goal is to develop a non-aggressive, high-efficiency approach for cetirizine hydrochloride analysis.

Methodology and Instrumentation

Sample preparation involved a working standard of 50 µg/mL cetirizine hydrochloride in 5:95 water/acetonitrile (v/v). Chromatographic conditions were:

• Column: Accucore HILIC 2.6 µm, 50 × 2.1 mm
• System: Thermo Scientific Accela HPLC with UV detection at 230 nm
• Mobile phase: 90:10 acetonitrile/200 mM ammonium acetate, pH 5.0
• Flow rate: 0.4 mL/min
• Column temperature: 30 °C
• Injection volume: 1.0 µL

Main Results and Discussion

Cetirizine eluted in less than 1 minute, representing a more than tenfold reduction in analysis time compared to the USP method (≈11 min). System suitability criteria were met with a tailing factor of 1.21, %RSD retention time of 1.39, and %RSD peak area of 0.17. The non-aggressive buffer preserved column and system integrity.

Benefits and Practical Applications

• High sample throughput due to sub-minute analysis.
• Elimination of corrosive acids reduces maintenance and prolongs equipment life.
• Precision and peak shape meet or exceed USP requirements.

Future Trends and Potential Applications

Superficially porous particles in HILIC mode show promise for rapid analysis of other polar pharmaceuticals and complex matrices. Future developments may include coupling with mass spectrometry for trace-level quantification and expanding method scope to related antihistamines.

Conclusion

The Accucore HILIC column offers a robust, rapid, and precise method for cetirizine hydrochloride analysis without aggressive acids. This approach enhances laboratory efficiency and instrument longevity, making it ideal for high-throughput QA/QC environments.

Reference

Thermo Fisher Scientific. Analysis of Cetirizine Hydrochloride Using a Core Enhanced Technology Accucore HPLC Column. Application Note ANCCSCETCHYDCHL, 2011.