Abstract
The aim of this work was to establish, optimize and validate a sensitive, selective and accurate thin layer chromatographic (TLC) method for determination of Phenylephrine (PHE), Dimetindene maleate (DM) and its major toxic impurity; 2-ethyl pyridine (EP), in raw material and nasal gel. The proposed method was applied for analysis of PHE, DM and EP over the concentration range of 1.00–10.0, 0.50–8.00 and 2.00–20.0 µg/band, respectively. The method is based on the separation of three components followed by densitometric measurement of the separated peaks at 254 nm. The separation was carried out on silica gel TLC F254 plates, using toluene: acetone: isopropyl alc.: ammonia (5.3: 2.7: 1.8: 0.4, by volume) as a developing system. The suggested method was validated according to International Conference on Harmonization guidelines and can be applied for routine analysis in quality control laboratories. The results obtained by the proposed method were statistically com-pared with the official method revealing high accuracy and good precision.
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