A Validated Reversed-Phase HPLC Analytical Method for the Analysis of Fenofibrate in Bulk Drug and Tablet Dosage Formulation
Awdhut Pimpale
Datta Meghe College of Pharmacy, Datta Meghe Institute of Medical Sciences (Deemed to be University), Wardha-442004, Maharashtra, India and Department of Pharmaceutical Sciences, RTM Nagpur University, Nagpur-440033, Maharashtra, India.
Rajendra Kakde *
Department of Pharmaceutical Sciences, RTM Nagpur University, Nagpur-440033, Maharashtra, India.
Ishwar Kakde
Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be University), Erandwane, Pune-411038, Maharashtra, India.
*Author to whom correspondence should be addressed.
Abstract
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.
Keywords: Fenofibrate, reverse phase-HPLC, validation