Abstract
A sensitive and specific automated procedure is described for the unit dose analysis of digitoxin and digoxin in tablet formulations. The technique is based on the fluorometric measurement of the dehydration products of the cardiotonic steroids, resulting from their reaction with hydrogen peroxide in concentrated hydrochloric acid. The automated system is capable of analyzing 12 tablets per hour with a relative standard deviation of ±1.4% at the 0.05-mg. digitoxin level. Accuracy of the procedure was determined by collecting comparative data on digitoxin tablets by both the automated method and the manual USP procedure. Specificity of the method, with respect to the analysis of intact digitoxin in the presence of the products of photochemical, alkaline hydrolytic, and thermal degradation, was demonstrated by comparison to quantitative TLC values. This method has also been shown to be applicable to the unit dose analysis of digoxin in the 0.02 to 1.0 mg./tablet range.
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