A stability-indicating assay for cefotaxime utilizing thin-layer chromatography with fluorescence detection.

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Cefotaxime is a widely used antibiotic.
• Monitoring cefotaxime degradation is crucial for drug safety and efficacy.
• Existing analytical methods may lack the sensitivity for trace-level impurities.

Purpose of the Study:

• To develop a highly sensitive method for analyzing cefotaxime and its degradation products.
• To improve the native fluorescence of cefotaxime and its related compounds.
• To establish an in situ quantitative analysis technique.

Main Methods:

• Thin-layer chromatography (TLC) on silica gel plates with a fluorescence indicator.
• Utilizing a chromatogram spectrophotometer for in situ fluorimetric quantitation.
• Optimizing TLC conditions to enhance native fluorescence.

Main Results:

• Achieved enhanced native fluorescence for cefotaxime and four degradation products.
• Developed a simultaneous in situ fluorimetric quantitation method.
• Demonstrated a detectability of 0.20 micrograms, which is 20 times more sensitive than HPLC-UV.
• Enabled the determination of degradation products at trace levels (1%).

Conclusions:

• The developed TLC-fluorimetric method offers superior sensitivity for cefotaxime analysis.
• This technique is effective for identifying and quantifying trace levels of cefotaxime degradation products.
• The method provides a valuable tool for pharmaceutical quality control and stability studies.