Abstract
The objective of the present investigation was to develop and validate a ‘green’ reversed phase high-performance liquid chromatography (RP-HPLC) method for rapid analysis of a cytotoxic drug 5-fluorouracil (5-FU) in bulk drug, marketed injection, water-in-oil (w/o) nanoemulsion, double water-in-oil-in-water (w/o/w) nanoemulsion and bacterial ghost (BG) matrix. The chromatography study was carried out at room temperature (25±1°C) using an HPLC system with the help of ultraviolet (UV)–visible detector. The chromatographic performance was achieved with a Nucleodur 150mm×4.6mm RP C8 column filled with 5µm filler as a static phase. The mobile phase consisted of ethyl acetate: methanol (7:3% v/v) which was delivered at a flow rate of 1.0mLmin−1 and the drug was detected in UV mode at 254nm. The developed method was validated in terms of linearity (r2=0.998), accuracy (98.19–102.09%), precision (% RSD=0.58–1.17), robustness (% RSD=0.12–0.53) and sensitivity with satisfactory results. The efficiency of the method was demonstrated by the assay of the drug in marketed injection, w/o nanoemulsion, w/o/w nanoemulsion and BG with satisfactory results. The successful resolution of the drug along with its degradation products clearly established the stability-indicating nature of the proposed method. Overall, these results suggested that the proposed analytical method could be effectively applied to the routine analysis of 5-FU in bulk drug, various pharmaceutical dosage forms and BG.
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•Environmentally benign RP-HPLC method has been applied for the assay of 5-FU.•The developed method was applied for the analysis of 5-FU in bacterial ghost matrix.•It was also applied for analysis of 5-FU in injection, w/o and w/o/w nanoemulsion.•Proposed method was found to be suitable for analysis of 5-FU in all samples.