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

Romi Singh; Abhiram Kumar; Ashutosh Pareek; Dipti Srivastava; Madhaw Kumar; Mohini Chaurasia; Swaran Flora

doi:10.1039/d5ay01843a

January 1, 2026Analytical Methods

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

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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.

Implication

Validation of an HPLC method quantifies fenofibrate in gel-matrix tablets, highlighting quality control applications.

Abstract

Aim: The present study aims to develop and validate a robust, sensitive HPLC method for the estimation of fenofibrate in a gel-matrix sustained-release tablet formulation designed to prevent alcohol-induced Dose...

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Cite This Study

Singh et al. (2026) studied this question.

synapsesocial.com/papers/69e9b77885696592c86eb475 https://doi.org/10.1039/d5ay01843a

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

Key Points

Implication

Abstract

Discussion

Cite This Study

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

Key Points

Implication

Abstract

Discussion

Cite This Study

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