A Validated Reversed-Phase HPLC Analytical Method for the Analysis of Fenofibrate in Bulk Drug and Tablet Dosage Formulation

Aims: A accurate, precise, and stability-indicating Reversed-Phase HPLC technique has been established for the estimation of fenofibrate in tablet formulation.

Study Design: Experimental study.

Place and Duration of Study: Department of Pharmaceutical Sciences, RTM Nagpur University, Nagpur-440033, Maharashtra, India between June 2019 and March 2020.

Methodology: The chromatographic separation was attained on RP Princeton column (C18) (250 mm x 4.6 mm, 5 µ) with mobile solvent system as a mixture of water (pH 3.0 along o-phosphoric acid) and acetonitrile in the proportion (40:60) v/v, flow rate 1.0 ml per minute, at 240 nm. The retention time of fenofibrate was 3.905 minutes.

Results: The method demonstrated linearity in the concentration range of 87-232 µg/ml with a coefficient of correlation (r2) of 0.9994. The % RSD was ˂2% and percentage recovery was found to be 99.13-100.74%. The assay of marketed tablet formulations was found to be 99.98%.

Conclusion: The developed and validated technique as per ICH rules for specificity, accuracy, precision, linearity, and system suitability. Reverse Phase-HPLC technique was utilized to the market formulation.