Isocratic RP-HPLC method for rutin determination in solid oral dosage forms

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Rutin is a flavonoid with potential health benefits, necessitating accurate quantification in pharmaceutical formulations.
• Existing methods for rutin determination may lack the required sensitivity or speed for routine quality control.

Purpose of the Study:

• To develop and validate a rapid and sensitive assay for the quantitative determination of rutin in oral dosage forms.
• To establish optimal conditions for isocratic reversed-phase high-performance liquid chromatography (RP-HPLC) analysis of rutin.

Main Methods:

• Development and validation of an isocratic RP-HPLC method using a C(18) column.
• Optimization of mobile phase composition (methanol-water, pH 2.8), flow rate (1 mL/min), and temperature (40°C).
• Assessment of linearity, limit of detection (LOD), limit of quantification (LOQ), precision, and robustness.

Main Results:

• The method demonstrated linearity in the concentration range of 8-120 µg/mL (R²=0.99982).
• Achieved LOD of 2.6 µg/mL and LOQ of 8.0 µg/mL, indicating high sensitivity.
• Intra- and inter-day precision were within acceptable limits, and the method proved robust, although mobile phase composition and pH significantly impacted separation.

Conclusions:

• The developed RP-HPLC method is suitable for the direct and accurate quantification of rutin in pharmaceutical dosage forms, even with excipients.
• The method's suitability is limited in the presence of structurally related compounds that may interfere with the analysis.