研究目的
To develop novel, simple, fast, and cost-effective spectrofluorimetric methods for the ultra-trace determination of Teicoplanin in pharmaceutical vials and human plasma, and to study its stability under various degradation conditions.
研究成果
The developed spectrofluorimetric methods are highly sensitive, accurate, and cost-effective for the determination of TEIC in pharmaceutical formulations and human plasma. They offer advantages over existing methods, such as higher sensitivity and reduced use of organic solvents, making them suitable for quality control and therapeutic drug monitoring. Future studies could explore applications in other biological fluids and further optimize the methods for clinical use.
研究不足
The methods may have limitations in specificity if interferents are present in complex matrices, and the stability of AgNPs could be affected by pH and storage conditions. The study is limited to in vitro analysis and may not fully represent in vivo conditions.
1：Experimental Design and Method Selection:
Two methods were designed: Method A measures native fluorescence of TEIC in methanol, and Method B uses silver nanoparticles (AgNPs) to enhance fluorescence without solvent extraction. Both methods are based on spectrofluorimetry with excitation at 335 nm and emission at 385 nm.
2：Sample Selection and Data Sources:
TEIC standard and pharmaceutical vials (Targocid? 400) were used. Human plasma samples were obtained from healthy volunteers after administration of TEIC.
3：List of Experimental Equipment and Materials:
Instruments include Scinco FS-2 spectrofluorimeter, laboratory centrifuge (Sigma 2-16KHL), scanning electron microscope (JEOL JSM-5400 LV), digital balance (FA2004), ultrasonic sonication homogenizer, and thermostatic water bath. Chemicals include TEIC, silver nitrate, potassium borohydride, sodium dodecyl sulfate, tween 80, beta-cyclodextrin, polyethylene glycol 400, polyoxyethylene 50 stearate, and various buffer solutions.
4：Experimental Procedures and Operational Workflow:
For Method A, TEIC solutions in methanol are prepared and fluorescence measured. For Method B, TEIC is mixed with buffer and AgNPs, then fluorescence measured. Applications include analysis in pharmaceutical vials and human plasma, with procedures for spiking, centrifugation, and measurement. Stability studies involve exposure to acidic, alkaline, oxidative, and photochemical degradation conditions.
5：Data Analysis Methods:
Calibration curves were constructed, and parameters like LOD, LOQ, accuracy, precision, selectivity, and robustness were evaluated using ICH and US-FDA guidelines. Statistical analysis included mean, standard deviation, and percentage recovery calculations.
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