Analysis of Lamivudine Using a Core Enhanced Technology Accucore HPLC Column

Importance of the Topic

Lamivudine is a critical antiretroviral agent widely used for treatment of HIV and hepatitis B infection. Fast and reliable quantification in pharmaceutical quality control ensures efficacy and safety of drug products.

Objectives and Study Overview

This study adapts the USP monograph method for lamivudine analysis to a high-throughput UHPLC format using Thermo Scientific Accucore aQ columns. The aim was to reduce analysis time and solvent consumption while maintaining compliance with USP acceptance criteria.

Methodology and Instrumentation

• Chromatographic system: Thermo Scientific Accela UHPLC with ChromQuest 5.0 software
• Column: Accucore aQ, 2.6 µm, 100 × 2.1 mm (Phase: C18 with polar endcapping)
• Mobile phase: 95:5 (25 mM ammonium acetate, pH 3.8):methanol
• Flow rate: 0.2 mL/min; Column temperature: 35 °C; Injection volume: 1.0 µL; Detection: UV at 277 nm
• Sample preparation: 700 µg/mL lamivudine in 50:50 methanol:water, diluted to 35 µg/mL

Main Results and Discussion

The USP method was successfully scaled down using a method transfer calculator from a 250 × 4.0 mm, 5 µm column to an Accucore aQ 100 × 2.1 mm, 2.6 µm column. Lamivudine eluted at 2.4 min, achieving a tailing factor below 2.0 and %RSD of retention time and peak area below 2%, based on six replicates. The reduced particle size and core–shell structure provided improved efficiency and lower backpressure compared to fully porous sub-2 µm materials.

Benefits and Practical Applications

• High sample throughput with run time under 5 min
• Reduced solvent usage and operating pressure
• Robust retention of polar analytes due to polar endcapping
• Compliance with USP monograph specifications for lamivudine

Future Trends and Opportunities

Advances in core–shell column technologies may further decrease analysis time and improve resolution for complex pharmaceutical matrices. Integration with automated sample preparation and data processing can enhance laboratory productivity and support regulatory compliance.

Conclusion

The Accucore aQ column enabled a rapid and efficient adaptation of the USP lamivudine assay to UHPLC, offering significant time and solvent savings while meeting all acceptance criteria.

Reference

• 1. HPLC method transfer calculator. http://www.hplctransfer.com/
• 2. USP monograph for lamivudine. http://www.pharmacopeia.cn/v29240/usp29nf24s0_m4423.html