ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FENOFIBRATE IN BULK AND FORMULATIONS VIA UV SPECTROPHOTOMETRY

Objective: The aim of the present work was developing the Ultra-violate (UV) spectroscopic analytical method for analysis of Fenofibrate in bulk and formulations. The drug is used for the treatment of primarily hypercholesterolemia and mixed dyslipidemia. Methods: The precise, convenient, simple, sensible and reproducible UV methods were developed, in solvents includes Methanol pure (A), Pure Polyethylene glycol (PEG)-400 (B), Ethanol: Propylene glycol (1:9) solution (EPG)-(C). Each were scanned in range of200-400 nm at concentration of 10µg/ml. The linearity with high sensitivity was obtained in UV spectrum, in therangefrom5-55μg/ml in solvents A, B and C, via Double beam UV-Visible Spectrophotometer. Validation was done as per ICH Q2B guideline parameters (Range, Linearity, Robustness, Precision, Ruggedness, Accuracy, Limit of detection (LOD) and Limit of quantification (LOQ), by using predefined calibration standards for the developed methods. Marketed formulation Lipicard-160 tablets I. P. was used for method validation in each solvent A, B and C. Results: The absorption maxima was observed in the solvents A, Band C, at 287.0 nm; 288.0 nm and286.0 nm, and the percentage average drug recovery was found to be 99.87; 99.74 and 98.76 respectively (n=6). Conclusion: The proposed method was successfully developed in chosen solvents and validated for the determination of Fenofibrate in bulk and formulations as per ICH Q2B parameters.