A Simple And Validated Spectrophotometric Analysis Method For The Hydrophobic Drug Fenofibrate In Natural Oils

Abstract

Objective: In this work, sodium lauryl sulfate (SLS) was used to present a simple spectrophotometry approach to more accurate
quantification of fenofibrate (FENO) concentration in five natural oils (soybean oil, lemon oil, black seed oil, cardamom oil, and garlic
oil). In the published work either organic solvent was used which may result in false results due to the dissolving of oil by organic
solvent, or high-performance liquid chromatography (HPLC) was utilized, which is a sophisticated instrument that may not be available
at every research facility.
Methods: construction of a calibration curve using a series of FENO concentrations added to 0.5% SLS phosphate buffer solution and
measuring the absorbance by spectroscopy at 289 nm. The drug samples in different oils were diluted with 0.5% SLS phosphate buffer
solution prior to direct reading by spectroscopy. According to the International Conference on Harmonization requirements, the method
was validated regarding specificity, precision, accuracy, and determination range.
Results: FENO gave absorbance maxima at 289 nm in 0.5% SLS solution, the beer’s law was obeyed in the range of 0.0125 to 0.05
mg/ml. High linearity (in the scope of 10 - 125 mg, R2=1), highly specific, good accuracy (95- 104), precision (SD< 10%), and a wide
range of detection, indicate validation of the procedure.
Conclusion: the proposed method for FENO analysis is simple, fast, and promising for easy determination of FENO in bulk and
pharmaceuticals.