Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
47, Number 7, August 2009, pp. 558-563
Validated High-Performance Liquid Chromatographic
Technique for Determination of 5-Fluorouracil: Applications to
Stability Studies and Simulated Colonic Media
Fars K. Alanazi1,2, Alaa Eldeen Yassin1,
Mahmoud El-Badry1,
Hammam A. Mowafy1, and Ibrahim A. Alsarra1
1Department of Pharmaceutics, College of Pharmacy, King Saud
University, P.O. Box 2457, Riyadh 11451, Saudi Arabia and
2Kayyali Chair
for Pharmaceutical Industry
A simple isocratic stability-indicating high-performance
liquid chromatographic method with UV detection using thymine
as an internal standard is developed. The method is validated
and the degradation products are determined. The method is applied
for the assessment of the stability of 5-fluorouracil in rat
caecal content as a simulated colon medium under anaerobic conditions.
The drug decomposes under acidic, alkaline, thermal, and oxidative
stress. The drug is highly susceptible to acidic, alkaline, and
oxidative hydrolysis as compared to alkaline conditions. Separation
of the drug from major and minor degradation products is successfully
achieved on a C18 analytical, µ-bondapak column.
The detection wavelength is 260 nm. The method is validated,
and the response is found to be linear in the drug concentration
range of 0.1–2.0 µg/mL.
The high linearity of the standard calibration curve of 5-fluorouracil
in the rat content is found to be R2 = 0.998
in the concentration range from 0.5 to 5 µg/mL. No degradation
occurred after incubation of 5-fluorouracil in the rat caecal
contents. The standard deviation and coefficient of variation
values for intra- and inter-day precision study exhibit acceptable
accuracy and precision data throughout the concentration range
investigated.
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