Analysis of Fenofibrate within JP method

Importance of the Topic

Fenofibrate is a widely prescribed lipid-lowering agent used to manage hyperlipidemia. Reliable quantification of this compound in pharmaceutical formulations is essential for quality control, regulatory compliance, and ensuring patient safety. The described reversed-phase liquid chromatography method offers a robust and accessible approach for routine analysis in research and industrial laboratories.

Objectives and Study Overview

This study presents a liquid chromatographic procedure tailored to the Japanese Pharmacopeia (JP) specifications for fenofibrate analysis. The primary goals are to achieve clear separation between fenofibrate and its related compound 4-chlorobenzophenone, to maintain a retention time near eight minutes, and to demonstrate method reproducibility under defined conditions.

Methodology

The chromatographic method is based on reversed-phase separation using an octadecylsilane (ODS) stationary phase and a binary mobile phase.

• Column temperature: 40 °C
• Mobile phase composition: acetonitrile : 0.02 M phosphate buffer (pH 3.0) = 70 : 30 (v/v)
• Flow rate: 0.95 mL/min (adjusted for ~8 min fenofibrate retention)
• Injection volume: 20 µL
• Detection wavelength: UV at 286 nm

Under these conditions, fenofibrate and the system suitability marker 4-chlorobenzophenone are baseline-resolved, ensuring accurate quantitation.

Main Results and Discussion

The optimized method consistently provided sharp, symmetric peaks for fenofibrate with a retention time of approximately eight minutes. System suitability tests indicated satisfactory resolution and peak symmetry, confirming the method’s reliability. Repeated injections demonstrated low variation in retention time and peak area, supporting the procedure’s suitability for routine quality control.

Benefits and Practical Applications

Implementation of this method delivers several advantages:

• Rapid analysis with moderate run time suitable for high-throughput environments
• Wide availability of required reagents and column chemistry
• Simple mobile phase preparation with common solvents and buffer
• Direct applicability to quality assurance and regulatory testing of fenofibrate formulations

Future Trends and Opportunities

Advancements may include adoption of sub-2 µm particle columns to reduce analysis time further, integration of mass spectrometric detection for enhanced specificity, and exploration of greener mobile phase components. Additionally, method transfer to ultra-high-performance liquid chromatography (UHPLC) platforms could improve throughput and solvent economy.

Conclusion

An RP-LC-UV method aligned with JP guidelines was established for fenofibrate determination. The procedure delivers reliable separation, reproducible performance, and practical utility for routine pharmaceutical testing.

Used Instrumentation

• Liquid chromatograph: Shimadzu Nexera XR
• Analytical column: Shim-pack VP-ODS (150 mm × 4.6 mm I.D., 5 µm)

References

• Application News 01-00184 (JP), Shimadzu Corporation, First Edition: December 2021, ERAS-1000-0288