CHROMATOGRAPHY, Vol. 22 (2001), No. 2, pp. 97-99

Analysis of the Active Ingredient Cimetidine in Acid Reduction Tablets By High Performance Thin Layer Chromatography with Ultraviolet Absorption Densitometry
Stacey D. Wagner and Joseph Sherma*
Department of Chemistry, Lafayette College
Easton PA 18042, USA
A quantitative method using silica gel HPTLC plates with fluorescent indicator, automated sample application, and UV absorption densitometry was developed for the determination of cimetidine in acid reduction tablets used to treat ulcers and other hyperacidity stomach disorders. Four pharmaceutical tablet products containing cimetidine as the active ingredient were analyzed to test the applicability of the new method. Precision was evaluated by replicate analyses of samples and accuracy by simultaneous analysis of unfortified and fortified samples on a single plate (standard addition). The percent cimetidine in the tablets analyzed ranged from 102% to 109% compared to label values, precision ranged from 1.2% to 2.2% relative standard deviation, and the error in the standard addition analysis was 0.985% compared to the fortification level. These validation levels are within the guidelines of the International Conference on Harmonization for pharmaceutical analysis.
Keywords: thin layer chromatography, cimetidine, densitometry.

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