Validation of a Highly Sensitive RP-HPLC Method for Quantification of Fenofibrate in Pure and Pharmaceutical Dosage Forms
Abid Mehmood Yousaf, Dong Wuk Kim, Han-Gon Choi and Euichaul Oh
Affiliation: College of Pharmacy & Institute of Pharmaceutical Science and Technology, Hanyang University, 1271, Sa-3-Dong, Ansan 426-791, South Korea.
A simple, sensitive, specific, robust, precise and accurate reverse-phase high performance liquid chromatographic
(RP-HPLC) method was developed and validated for suitable quantitation of fenofibrate in bulk and pharmaceutical
dosage forms. The investigation of various validation parameters such as system suitability, linearity, detection limit,
quantification limit, precision, accuracy, specificity, robustness and stability was accomplished in accordance with the International
Conference on Harmonization (ICH) guidelines. The isocratic elution of fenofibrate was performed using Agilent
1260 Infinity HPLC system. The column was Capcell PAK C18 (4.6 mm x 250 mm, 5 μm). The mobile phase, consisted
of acetonitrile and 0.1% (v/v) H3PO4 (75:25, v/v), was eluted at 2 ml/min. The eluent was monitored at 286 nm by
the UV detector for fenofibrate concentration measurement. Stability test proved that fenofibrate in sample solutions remained
stable at room temperature throughout the analytical process. The limit of detection (LOD) and limit of quantification
(LOQ) furnished by this method were better than those of the previously reported HPLC and some UPLC methods of
fenofibrate determination. All other validation parameters appeared within the acceptable limits.
Keywords: Acetonitrile, dosage form, fenofibrate, RP-HPLC, validation.
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