Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
46, Number 1, January 2008, pp. 4-9
Stability-Indicating Thin-Layer Chromatographic
Method for Quantitative Determination of Ribavirin
Ibrahim A. Darwish[1], Hassan F. Askal[1], Alaa
S. Khedr[1], and Ramadan M. Mahmoud[2]
[1]Department of Pharmaceutical Analytical Chemistry, Faculty
of Pharmacy, Assiut University, Assiut 71526, Egypt and
[2]Department
of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy,
Al-Azhar University, Assiut, 71524, Egypt
A simple and accurate stability-indicating thin-layer
chromatographic (TLC) method is developed and validated for the
quantitative determination of ribavirin (RBV) in its bulk and
capsule forms. The method employs TLC aluminum plates precoated
with silica gel 60F-254 as a stationary phase. The solvent system
used for development consists of chloroform–methanol–acetic
acid (60:15:15, v/v/v). The separated spots are visualized as
bluish green spots after being sprayed with anisaldehyde reagent.
RBV is subjected to different accelerated stress conditions.
The drug is found to undergo degradation under all stress conditions,
and the degradation products are well resolved from the pure
drug with significantly different Rf values. The optical densities
of the separated spots are found to be linear with the amount
of RBV in the range of 5–40 µg/spot with a good correlation
coefficient (r = 0.9980). The limit of detection and limit of
quantitation values are 1.40 and 4.67 µg/spot, respectively.
Statistical analysis proves that the method is repeatable and
accurate for the determination of RBV in the presence of its
degradation products. The method meets the International Conference
on Harmonisation/Food and Drug Administration regulatory requirements.
The proposed TLC method is successfully applied for the determination
of RBV, pure and in capsules, with good accuracy and precision;
the label claim percentages are 98.8% ± 1.5%. The results
obtained by the proposed TLC method are comparable with those
obtained by the official method.
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