Summary of - Analytical and Bioanalytical HPLC Method for Simultaneous estimation of 5-Fluorouracil and Sonidegib

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Article

Abstract

Study Background: The increasing need for effective cancer treatments has led to the development of combination therapies, such as 5-fluorouracil (5-FU) and Sonidegib (SDG), both of which are used in cancer treatment. However, the simultaneous quantification of these drugs in different formulations and biological matrices poses a significant analytical challenge. Accurate and sensitive methods are essential for evaluating their pharmacokinetics and ensuring consistent drug delivery in therapeutic applications. Research Goals and Hypotheses: The primary goal of this study was to develop a novel, sensitive, and reliable reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of 5-FU and SDG. The hypothesis was that the developed RP-HPLC method would provide accurate, specific, and reproducible quantification of both drugs in bulk, nano formulations, and rat plasma, making it suitable for pharmacokinetic studies. Methodological Approach: The study utilized gradient elution RP-HPLC techniques to separate and quantify 5-FU and SDG. The analytes were separated on a Luna® C18 column using a mobile phase composed of acetonitrile and acidified water. For biological samples, 5-FU and SDG were extracted from rat plasma using liquid–liquid extraction. The method was validated for specificity, sensitivity, and stability, ensuring its applicability in different matrices. Results and Discoveries: The developed RP-HPLC method successfully separated 5-FU and SDG with high specificity and sensitivity. The method was validated and applied to a single-dose oral pharmacokinetic study in Wistar rats, demonstrating its robustness in analyzing both drugs in nano formulations and plasma. The study confirmed that the method is a reliable analytical tool for the simultaneous estimation of 5-FU and SDG in various research and clinical applications.

DOI: https://doi.org/10.4155/bio-2021-0212

Publication Date: 2022

Recommended citation: Padya, B. S., Hegde, A. R., Mutalik, S. P., Biswas, S., & Mutalik, S. (2022). Analytical and bioanalytical HPLC method for simultaneous estimation of 5-fluorouracil and sonidegib. Bioanalysis, 14(1), 29-45.

Publication Date

2022

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