A new fluorescence probe for sofosbuvir analysis in dosage form and spiked human plasma
Mohamed S Nasr1, Wael Talaat1, Samir Morshedy1
1Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt.
Summary
A new, cost-effective fluorescence quenching method accurately analyzes the hepatitis C drug sofosbuvir in various forms. This technique offers reliable quantification in bulk, tablets, and plasma samples.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Accurate quantification of antiviral drugs like sofosbuvir is crucial for hepatitis C treatment.
- Existing analytical methods may be complex, costly, or time-consuming.
Purpose of the Study:
- To develop a simple, rapid, and low-cost analytical technique for sofosbuvir.
- To validate the method for analyzing sofosbuvir in bulk, tablet formulations, and human plasma.
Main Methods:
- Utilized a novel fluorescent reagent (2-amino-3-cyano-4,6-dimethylpyridine) that is quenched by sofosbuvir.
- Optimized experimental variables affecting the fluorescence quenching process.
- Validated analytical parameters including linearity, accuracy, precision, LOD, and LOQ according to ICH guidelines.
Main Results:
- The developed method demonstrated linearity between 0.1 and 1.5 μg/mL.
- Successful analysis of sofosbuvir in tablet form with mean recoveries of 100.13 ± 0.35%.
- Effective quantification in spiked human plasma with mean recoveries of 94.26 ± 1.69%.
Conclusions:
- The developed fluorescence quenching method is a reliable and efficient tool for sofosbuvir analysis.
- This technique offers a practical solution for quality control and therapeutic drug monitoring.
- The method's simplicity and low cost make it suitable for widespread application.
