Analysis of Ivermectin - High Speed Analysis of Pharmaceutical Impurities

Importance of Topic

In modern pharmaceutical analysis rapid and reliable detection of active compounds and impurities is critical to ensure product quality and safety. Ivermectin, a widely used macrolide antiparasitic agent, requires efficient analytical workflows to meet stringent regulatory requirements and support high throughput in research and quality control settings.

Objectives and Study Overview

This application note presents a comparative evaluation of conventional high performance liquid chromatography and a high speed ultrahigh performance liquid chromatography workflow for determination of ivermectin at 0.8 mg/mL. The study aims to demonstrate how optimized column dimensions and flow rates can reduce analysis time while maintaining resolution and sensitivity.

Methodology and Instrumentation

• System: Shimadzu Nexera-i MT
• Conventional column: Shim-pack GIST C18 250 mm x 4.6 mm id 5 μm, flow rate 1.0 mL/min
• High speed column: Shim-pack GIST C18 150 mm x 4.6 mm id 3 μm, flow rate 1.5 mL/min
• Mobile phase composition: water/methanol/acetonitrile in ratio 15/34/51 v/v/v
• Column temperature: 25 °C
• Injection volume: 20 μL
• Detection: UV at 254 nm

Main Results and Discussion

Comparison of chromatograms reveals that the high speed UHPLC configuration reduces overall run time by approximately 40 percent without compromising peak shape or resolution of the ivermectin analyte. Retention time is shifted earlier under increased flow rate and smaller particle size, demonstrating improved mass transfer kinetics. Baseline stability and detector response remain consistent across both setups, confirming method robustness.

Benefits and Practical Applications

• Significant time savings per sample support higher daily throughput in routine analysis.
• Maintained sensitivity and resolution ensure reliable detection of ivermectin and potential impurities.
• Compatibility with existing reversed phase workflows allows straightforward method transfer.
• Reduced solvent consumption per analysis lowers operational costs and environmental impact.

Future Trends and Potential Applications

Ongoing advances in column chemistry, including core shell and sub-2 micron materials, will further accelerate analysis times while enhancing resolution of complex mixtures. Integration with mass spectrometry detection can extend this approach to multi-residue screening in food, veterinary and pharmaceutical matrices. Automated method development tools promise to streamline optimization of gradient profiles and mobile phase compositions.

Conclusion

The high speed reversed phase method using a Shim-pack GIST C18 150 mm x 4.6 mm id 3 μm column on a Nexera-i MT system provides an efficient and reliable workflow for ivermectin analysis. This approach delivers reduced run times, consistent chromatographic performance and practical benefits for quality control laboratories.

Reference

• Application News L518 Shimadzu Corporation Dec 2021 ERAS-1000-0117