Abstract
In the current work, RP-HPLC method was developed and validated for simultaneous analysis of 5-Fluorouracil (5-FU) and silibinin from corn-derived protein polysaccharide nanocomplex. The method employs a mobile phase of water (A) and acetonitrile: methanol (60:40) (B) on a Waters C18 column (4.6 x 150 mm, 5 μm), with detection wavelengths set at 266 nm and 288 nm for 5-FU and silibinin, respectively. The runtime was 15 min at a flow rate of 0.7 mL/min. The analytical method validation adhered closely to ICH guidelines, exhibiting remarkable selectivity, specificity, linearity, and precision, all falling comfortably within acceptable thresholds. The analytical method was found to be linear from 1 to 150 µg/mL with R2 of 0.9998. Forced degradation studies were carried to assess the stability of 5-FU and silibinin within the nanocomplex across diverse conditions. Additionally, nanocomplexes loaded with 5-FU and silibinin were formulated and characterized, demonstrating a particle size of 209.83 ± 3.83 nm and a zeta potential of 57.93 ± 1.06 mV. The %entrapment efficiency for 5-FU and silibinin was found to be 88.73 ± 0.37 % and 97.00 ± 1.58 % with a %drug loading of 6.73 ± 0.92 % and 2.74 ± 0.61 % respectively. The %in vitro drug release was determined using developed and validated analytical methods. Further, various release kinetic models were applied to determine the release behavior from the nanocomplex system. To conclude, we ensured the eco-friendliness of the developed analytical method by assessing its greenness through Eco-scale, the green analytical procedure index (GAPI), and the Analytical GREEnness metric (AGREE).
Published Version
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