Stability-indicating thin-layer chromatographic method for quantitative determination of ribavirin

Abstract

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.