USP Method Transfer and UPLC Method for Analysis of Telmisartan Tablets

Significance of the Topic

The analysis of telmisartan in pharmaceutical dosage forms is critical for ensuring product quality, patient safety and regulatory compliance. High performance liquid chromatography (HPLC) methods for compendial assays are well established, but modern demands for faster throughput, lower solvent consumption and increased laboratory efficiency drive adoption of ultra performance liquid chromatography (UPLC) technologies.

Study Objectives and Overview

This work describes the transfer of the United States Pharmacopeia (USP) Telmisartan Tablets assay from an HPLC platform to UPLC with sub-2 μm particle columns. The primary aims were to shorten run times, sharpen chromatographic peaks and reduce solvent and sample consumption while maintaining USP system suitability criteria over extended routine use.

Methodology

The original USP method uses an isocratic mobile phase (70:30 methanol:17 mM ammonium dihydrogen phosphate buffer, pH 3.0) on a 4.6 × 50 mm, 5 μm HSS T3 column at 0.7 mL/min with UV detection at 298 nm. The UPLC adaptation employs a 2.1 × 30 mm, 1.8 μm HSS T3 column at 0.41 mL/min under identical buffer and detection conditions. Sample and standard solutions were prepared by dissolving tablets or reference materials in 0.005 N NaOH/methanol, followed by dilution with mobile phase to target concentrations.

Used Instrumentation

• Alliance HPLC system with 2489 UV/Visible detector
• ACQUITY UPLC system with PDA detector
• XSelect HSS T3 HPLC column, 4.6 × 50 mm, 5 μm
• ACQUITY UPLC HSS T3 column, 2.1 × 30 mm, 1.8 μm
• Empower 2 chromatography data software

Key Results and Discussion

Switching to UPLC achieved a 75 % reduction in analysis time (1.5 min vs. 6 min), an 86 % decrease in mobile phase and an 88 % reduction in sample volume per injection. Chromatographic peaks were noticeably narrower on UPLC, and system suitability parameters (peak tailing, capacity factor, resolution and %RSD) met or exceeded USP requirements on both platforms. A prolonged study of 3000 injections using the UPLC method demonstrated stable pressure profiles, consistent peak shapes and only minor tailing after ~2100 injections, which was restored by routine column washing.

Benefits and Practical Applications

• Significant cost savings through reduced solvent and sample usage
• Enhanced throughput supporting high-volume quality control labs
• Maintained compliance with USP monograph criteria
• Demonstrated column robustness over thousands of injections

Future Trends and Opportunities

Further developments may include integration of mass spectrometry detection for enhanced specificity, automated sample preparation workflows and adoption of even smaller particle chemistries or core-shell columns. Miniaturized flow systems and green solvent alternatives will continue to drive sustainability and efficiency in pharmaceutical analysis.

Conclusion

The successful transfer of the USP telmisartan tablet assay from HPLC to UPLC delivers faster, greener and equally robust analysis. UPLC technology provides laboratories with substantial time and cost efficiencies without compromising method performance or regulatory compliance.

Reference

• 1. Telmisartan – Oral, Micardis. MedicineNet.com.
• 2. USP Monograph, Telmisartan Tablets, USP33-NF28.
• 3. Jones M.D.; Alden P.; Fountain K.J.; Aubin A. Implementation of Methods Translation between Liquid Chromatography Instrumentation, Waters Application Note 720003721EN.