Central composite design optimized fluorescent method using dual doped graphene quantum dots for lacosamide...

Area of Science:

• Analytical Chemistry
• Materials Science
• Pharmacology

Background:

• Lacosamide is a crucial third-generation antiepileptic drug for managing partial-onset seizures.
• Accurate quantification of lacosamide in biological samples and pharmaceuticals is essential for effective treatment and quality control.
• Existing analytical methods may have limitations in sensitivity, sustainability, or applicability.

Purpose of the Study:

• To develop and validate a novel, sensitive, and sustainable analytical method for lacosamide determination.
• To utilize boron and nitrogen co-doped graphene quantum dots (BN-GQDs) for fluorescence-based detection of lacosamide.
• To assess the method's performance according to ICH M10 guidelines and evaluate its environmental impact.

Main Methods:

• Synthesis and characterization of boron and nitrogen co-doped graphene quantum dots (BN-GQDs).
• Development of a fluorescence quenching-based assay for lacosamide detection.
• Optimization of reaction parameters using a central composite design.
• Validation of the analytical method for linearity, limit of detection, accuracy, precision, selectivity, and robustness.
• Application of the method to real human plasma samples and pharmaceutical formulations.
• Environmental impact and sustainability assessment.

Main Results:

• The developed BN-GQDs exhibited strong fluorescence properties, which were quenched by lacosamide.
• The fluorescence quenching mechanism was elucidated using density functional theory and Stern-Volmer analysis.
• The method demonstrated excellent linearity (0.1-5 µg/mL) and a low limit of detection (0.033 µg/mL).
• Validation results met ICH M10 guidelines, confirming accuracy, precision, selectivity, and robustness.
• The method was successfully applied for lacosamide quantification in pharmaceutical formulations and pharmacokinetic studies.
• The proposed method showed significant improvements in environmental impact and sustainability.

Conclusions:

• A novel, sensitive, and validated fluorescence quenching method for lacosamide determination using BN-GQDs has been established.
• The method is suitable for bioanalytical applications, including therapeutic drug monitoring and quality control of lacosamide.
• The use of BN-GQDs offers a sustainable and environmentally friendly alternative for lacosamide analysis.