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Stability-indicating thin-layer chromatographic method for quantitative determination of ribavirin
Ibrahim A Darwish1, Hassan F Askal, Alaa S Khedr
1Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, Assiut 71526, Egypt. idarwish@ksu.edu.sa
Journal of Chromatographic Science
|January 26, 2008
Summary
A new thin-layer chromatographic (TLC) method accurately quantifies ribavirin (RBV) and its degradation products. This validated method ensures drug stability and meets regulatory standards for pharmaceutical analysis.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Ribavirin (RBV) is an antiviral medication requiring robust analytical methods for quality control.
- Assessing drug stability and quantifying impurities are critical for pharmaceutical product safety and efficacy.
Purpose of the Study:
- To develop and validate a simple, accurate, and stability-indicating thin-layer chromatographic (TLC) method for ribavirin (RBV).
- To determine RBV in bulk and capsule formulations, including its degradation products.
Main Methods:
- Thin-layer chromatography (TLC) using a chloroform-methanol-acetic acid mobile phase.
- Visualization with anisaldehyde reagent and densitometric scanning.
- Forced degradation studies under various stress conditions.
Main Results:
- The TLC method demonstrated good linearity (r=0.9980) for RBV quantification (5-40 microg/spot).
- Degradation products were well-resolved from RBV, with low limits of detection (1.40 microg/spot) and quantitation (4.67 microg/spot).
- The method showed high accuracy (98.8%+/-1.5%) and precision, meeting ICH/FDA requirements.
Conclusions:
- The developed TLC method is stability-indicating, accurate, and precise for ribavirin analysis.
- It is suitable for routine quality control of ribavirin in bulk and pharmaceutical formulations.
- The method's performance is comparable to official analytical techniques.
