Development and validation of QbD-Integrated sensitive RP-HPLC method for quantitation of Fenofibrate: An application in quality control

Key Points

• To develop and validate a sensitive RP-HPLC method for quantifying fenofibrate in sustained-release tablets.
• Developed a robust HPLC method using a gel-matrix formulation.
• Conducted validation tests to assess sensitivity and accuracy.
• Applied Quality by Design (QbD) principles during method development.
• Successfully quantified fenofibrate with high sensitivity.
• The method showed consistency in tests, meeting quality control standards.
• Demonstrated effectiveness in preventing alcohol-induced dose variations.