Development and Validation of Isocratic RP-UHPLC Method for Assay of Fenofibrate Tablet

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Fenofibrate is a widely used lipid-regulating agent.
• Accurate and efficient analytical methods are crucial for pharmaceutical quality control.

Purpose of the Study:

• To develop and validate a rapid and precise analytical method for fenofibrate assay in tablet dosage forms.
• To compare the efficiency of the developed method with existing High-Performance Liquid Chromatography (HPLC) methods.

Main Methods:

• Isocratic Reversed-Phase Ultra-High-Performance Liquid Chromatography with UV detection (RP-UHPLC-UV).
• Shim-pack Velox C18 column (50 × 2.1 mm, 1.8 μm) at 40°C.
• Mobile phase: acidified water/acetonitrile (60:40, v/v) at 0.4 mL/min, detection at 286 nm.

Main Results:

• The method demonstrated linearity over the range of 10-90 μg/mL (r² = 0.9995).
• Limit of Detection (LOD) and Limit of Quantitation (LOQ) were 0.239 μg/mL and 0.673 μg/mL, respectively.
• High precision (RSD < 2%) and accuracy (96%-100% recovery) were achieved, meeting ICH Q2(R1) guidelines.

Conclusions:

• The developed RP-UHPLC-UV method is rapid, precise, and sensitive for fenofibrate assay.
• This method significantly reduces analysis time and solvent consumption compared to traditional HPLC methods.
• The validated method is suitable for routine quality control of fenofibrate tablets.