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Published on: February 3, 2014
Spectrofluorometric determination of futibatinib in human plasma and pharmaceutical formulations
Rami M Alzhrani1, Atiah H Almalki2, Manal E Alosaimi3
1Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi Arabia.
Abstract:
Futibatinib is a powerful inhibitor of fibroblast growth factor receptors that impedes its phosphorylation and subsequently leading to a reduction in in cell viability across various cell lines. Futibatinib was approved for initial use as an effective treatment for several diseases, including non-small cell lung cancer and breast cancer. Herein, a novel selective fluorescence probe was created for futibatinib quantification in various matrices, including pharmaceutical formulation and human plasma. The technique primarily depends on futibatinib's chemical conversion into a fluorescent product through a reaction with trimethylamine and bromoacetyl bromide. The created fluorescent probe exhibits maximum emission peak at 338 nm upon excitation at 248 nm. The method provided a low detection limit of 0.120 ng/mL and maintained a linear concentration-dependent relationship across the range of 1-200 ng/mL. High sensitivity, accuracy and precision were demonstrated for futibatinib quantification in pharmaceutical formulation and spiked plasma matrix by the method, which was validated in accordance with ICH requirements.
Insights
A new fluorescence probe accurately quantifies futibatinib, a fibroblast growth factor receptor inhibitor used in cancer treatment. This method offers high sensitivity for detecting futibatinib in drug formulations and human plasma.
Area of Science:
- Analytical Chemistry
- Pharmacology
- Biochemistry
Background:
- Futibatinib is a potent fibroblast growth factor receptor (FGFR) inhibitor.
- It is approved for treating cancers like non-small cell lung cancer and breast cancer.
- Accurate quantification of futibatinib is crucial for therapeutic drug monitoring and quality control.
Purpose of the Study:
- To develop a novel, selective fluorescence probe for futibatinib quantification.
- To validate the probe's efficacy in pharmaceutical formulations and human plasma.
- To establish a sensitive and reliable analytical method for futibatinib.
Main Methods:
- Chemical conversion of futibatinib to a fluorescent product using trimethylamine and bromoacetyl bromide.
- Spectrofluorometric analysis with excitation at 248 nm and emission at 338 nm.
- Method validation according to International Council for Harmonisation (ICH) guidelines.
Main Results:
- The fluorescence probe exhibited high sensitivity with a low detection limit of 0.120 ng/mL.
- A linear concentration-dependent relationship was observed between 1-200 ng/mL.
- The method demonstrated high accuracy and precision for futibatinib quantification in pharmaceutical and plasma matrices.
Conclusions:
- A novel and selective fluorescence probe method for futibatinib quantification has been successfully developed.
- The method is highly sensitive, accurate, and precise, suitable for pharmaceutical and biological samples.
- This assay provides a valuable tool for futibatinib analysis in clinical and research settings.
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