研究目的
To develop a validated, responsive, and rapid spectrofluorimetric method for quantifying ondansetron (OND) in authentic form, spiked human plasma, and dosage forms, and to apply this method to degradation studies of OND under various conditions.
研究成果
The developed spectrofluorimetric method is rapid, cost-effective, and suitable for the estimation of OND in various pharmaceutical formulations and spiked human plasma. It serves as an alternative to more complex analytical techniques and is applicable for stability studies under different degradation conditions.
研究不足
The method's robustness was tested with minor variations in Triton X-100 volume, but more extensive robustness testing under a wider range of conditions could further validate the method. The study also notes that the drug was stable only under thermal degradation, with significant degradation observed under other conditions.
1：Experimental Design and Method Selection:
The study involved the development of a spectrofluorimetric method for OND quantification in a Triton X-100 system, optimizing various variables affecting fluorescence response.
2：Sample Selection and Data Sources:
Samples included authentic OND, spiked human plasma, and pharmaceutical dosage forms (tablets, syrup, injection).
3：List of Experimental Equipment and Materials:
FLUOROMAX-4 spectrofluorimeter, Remi Cyclo mixer CM 101, Shimadzu AUW–220D digital balance, REMI Labtech ultracentrifuge, and various chemicals including Triton X-100, SDS, CTAB, and β-CD.
4：Experimental Procedures and Operational Workflow:
Included preparation of standard solutions, calibration curves, forced degradation studies under various conditions (acidic, alkaline, oxidative, photolytic, thermal), and application to pharmaceutical preparations and spiked human plasma.
5：Data Analysis Methods:
Statistical analysis of regression data for linearity, accuracy, precision, robustness, and application to pharmaceutical and plasma samples.
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