Abstract
A quantitative method, using high performance thin layer chromatography (HPTLC) with automated sample application and UV-absorption scanning densitometry, was developed for the determination of diphenhydramine hydrochloride and doxylamine succinate in pharmaceutical sleep aid products. Separation was performed on high performance silica gel plates, and the analytes were detected as fluorescence-quenched zones under 254 nm UV light. Three pharmaceutical products containing diphen-hydramine hydrochloride as an active ingredient, and three containing doxylamine succinate as an active ingredient, were analyzed to test the applicability of the method. Precision was validated by replicate analyses of samples and accuracy by analysis of spiked samples. The percent diphenhydramine hydrochloride in the tested pharmaceutical samples ranged from 97.9% to 113% compared to label values; precision ranged from 0.69% to 2.36% relative standard deviation, and the errors in standard addition experiments used to test accuracy varied between 0.00% and 0.26% compared to fortification levels. For doxylamine succinate, samples assayed at 93.9–107% relative to the label declaration; precision ranged from 0.75% to 2.13%, and errors from standard addition and blank spike analyses were 0.38% and 1.59%, respectively.
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