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Quantitative thin-layer chromatographic method for determination of amantadine hydrochloride
Hassan F Askal1, Alaa S Khedr, Ibrahim A Darwish
1Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, Egypt;
International Journal of Biomedical Science : IJBS
|May 16, 2013
Summary
A new thin-layer chromatographic (TLC) method accurately quantifies amantadine hydrochloride (AMD). This simple, validated technique is stable under stress conditions and suitable for global laboratory use.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Amantadine hydrochloride (AMD) is an antiviral and antiparkinsonian agent.
- Accurate quantification methods are essential for pharmaceutical quality control.
Purpose of the Study:
- To develop and validate a simple, accurate, and robust thin-layer chromatographic (TLC) method for the quantitative determination of amantadine hydrochloride (AMD).
Main Methods:
- Quantitative determination using TLC on silica gel 60F-254 plates.
- Solvent system: n-hexane-methanol-diethylamine (80:40:5, v/v/v).
- Visualization via modified Dragendorff's reagent; detection by scanner.
Main Results:
- The method demonstrated linearity over 5-40 µg/spot (r=0.9994).
- Limits of detection (LOD) and quantitation (LOQ) were 0.72 and 2.38 µg/spot.
- AMD stability confirmed under various stress conditions (heat, acid/alkali, oxidation, UV).
- Method validated for accuracy, precision, and robustness, meeting ICH/FDA requirements.
- Successfully applied to bulk and capsule samples (99.0 ± 1.0% label claim).
Conclusions:
- The developed TLC method is simple, accurate, precise, and robust for AMD quantification.
- The method is cost-effective and suitable for widespread laboratory application.
- AMD is stable under investigated accelerated stress conditions.
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