Development and Validation of UV Spectrophotometric Method for Simultaneous Quantification of Diosgenin and Fisetin in Bulk and Pharmaceutical Formulations

Abstract

Diosgenin and fisetin are important bioactive compounds with significant pharmaceutical applications. A simple, accurate, and cost-effective analytical method is needed for their simultaneous determination in pharmaceutical formulations. The method was developed using methanol as solvent and distilled water for dilution. Standard solutions were prepared and analyzed at their respective λmax values. The method was validated according to ICH guidelines for linearity, accuracy, precision, repeatability, ruggedness, limit of detection (LOD), and limit of quantification (LOQ). The λmax for diosgenin and fisetin were found to be 210 nm and 360 nm, respectively. Linear relationships were established over concentration ranges of 1-5 μg/mL for diosgenin and 2-10 μg/mL for fisetin. The regression equations were y = 0.1865x + 0.0016 (r² = 0.9954) for diosgenin and y = 0.0944x + 0.0092 (r² = 0.9924) for fisetin. Recovery studies showed 99.67-100.13% for diosgenin and 99.93-100.37% for fisetin. The method demonstrated excellent precision with %RSD values less than 2% for all parameters. The developed UV spectrophotometric method is simple, accurate, precise, and suitable for routine quality control analysis of diosgenin and fisetin in pharmaceutical formulations.