HPLC-UV Method for the Determination of Telmisartan Using a Syncronis C8 1.7 μm Column

Significance of the Topic

Reliable and reproducible HPLC–UV methods are crucial for the quality control of pharmaceuticals. Telmisartan, an angiotensin II receptor antagonist used in hypertension therapy, demands fast and accurate quantification to meet regulatory and clinical standards.

Objectives and Study Overview

This application study evaluates the performance of the Thermo Scientific Syncronis C8 1.7 µm column in the rapid determination of telmisartan by HPLC–UV, focusing on retention time, peak shape, and method reproducibility.

Methodology and Instrumentation

Key experimental parameters and instrumentation:

• UHPLC system: Thermo Scientific Accela
• Column: Syncronis C8, 1.7 µm particle size, 50 × 2.1 mm
• Mobile phase: 65:35 v/v of 20 mM ammonium acetate/acetonitrile
• Flow rate: 0.20 mL·min⁻¹
• Column temperature: 25 °C
• Injection volume: 1 µL (partial loop)
• UV detection wavelength: 230 nm
• System backpressure: ~215 bar
• Standard solution: 20 µg·mL⁻¹ telmisartan in water

Main Results and Discussion

The method achieved baseline separation of telmisartan in under 3 minutes. Six replicate injections yielded highly consistent performance:

• Average retention time: 1.98 min (RSD 0.3%)
• Peak asymmetry: 1.39 (RSD 0.4%)
• Stable backpressure and minimal baseline noise

The narrow peak width and low variability demonstrate the column’s high efficiency and reproducibility, attributed to its pure silica, dense bonding, and double endcapping.

Benefits and Practical Applications

The Syncronis C8 1.7 µm column offers:

• Rapid analysis with throughput suitable for high-volume QC laboratories
• Excellent peak symmetry and resolution for telmisartan
• Robust performance with minimal method development effort
• Compatibility with standard HPLC–UV systems for straightforward implementation

Future Trends and Potential Applications

Advances in chromatographic technologies may further enhance pharmaceutical analysis:

• Miniaturized and micro-UHPLC systems for reduced solvent consumption
• Coupling with mass spectrometry for multi-component profiling and trace-level detection
• Integration of green chemistry principles to lower environmental impact
• Automation and online sample preparation for streamlined workflows
• Application to metabolite and impurity profiling in clinical and regulatory studies

Conclusion

The Thermo Scientific Syncronis C8 1.7 µm column delivers fast, reliable, and reproducible HPLC–UV analysis of telmisartan, making it an excellent choice for pharmaceutical quality control and routine method implementation.

References

• MacRitchie E. HPLC–UV Method for the Determination of Telmisartan Using a Syncronis C8 1.7 µm Column. Thermo Fisher Scientific; 2011.