Abstract
Rebamipide (RBP), α((4-chlorobenzoyl)-amino)-1,2-dihydro-2-oxo-4-quinoline propanoic acid is antiulcer (gastric cytoprotectant). Literature survey revealed many reverse-phase high-performance liquid chromatography (RP-HPLC) methods for determination of RBP in human plasma, rat plasma, and coionic tissue. Stability-indicating liquid chromatographic assay method and first-order derivative spectrophotometric methods have been established for the determination of RBP in bulk and tablet dosage form. Nowadays, high-performance thin-layer chromatography (HPTLC) is becoming a routine analytical technique due to its low operating cost, high sample throughput, and need for minimum sample clean up. The major advantage of HPTLC is that several samples can be run simultaneously using a small quantity of mobile phase unlike HPLC, thus lowering analysis time and cost per analysis. The intention of the present work is to establish simple, precise, and accurate stability-indicating densitometric thin-layer chromatography (TLC)-densitometry method for analysis of RBP in the bulk material and in tablets. Further the developed method has to be validated as per the International Conference on Harmonisation (ICH) guidelines.
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