Development and Validation of a UV Spectrophotometric Method for the Simultaneous Estimation of 5-Fluorouracil and Xanthone with Application to Ultradeformable Liposomes for Cancer Therapy

The objective of this research is to establish a precise, simple and rapid UV spectroscopic technique for the simultaneous estimation of 5-Fluorouracil (5-FU) and Xanthone (XAN) in a combination dosage form. The absorption maxima (λmax) for 5-FU and XAN were recorded at 263 and 258 nm, respectively. Both drugs obey Beers' law within the concentration limits of 2-12µg/ml. A high degree of linearity was attained with correlation coefficient values of 0.9929 for 5-FU and 0.9977 for XAN. The technique was validated according to ICH Q2(R1) guideline exhibiting acceptable accuracy, precision, specificity, LOD of 1.2418 µg/ml and 1.2467µg/ml, while LOQ of 3.765µg/ml and 3.778µg/ml for 5-FU and XAN, respectively. Recovery study (%RSD) showed values ranging from 98 to 102.1% for 5-FU and from 82.3 to 90% for XAN. The results of the developed methods were statistically validated and exhibited consistent performance. The findings verify that this method is reliable and can be effectively implemented for the simultaneous determination of 5-FU and XAN, loaded in an ultradeformable liposome (UDLs) formulation. The established method is essential for quantifying the drugs and supporting formulation characterization parameters such as percent entrapment efficiency and drug release profile.