Green HPTLC-densitometric approach for simultaneous determination and impurity- profiling of ebastine and phenylephrine hydrochloride

Abstract

Although analytical HPLC-technique can be considered as a well-accepted versatile approach for the drugs' separation, quantification, as well as impurity profiling, its regular adoption shows increasing environmental concerns provoked by high energy-consumption, instrument and solvents costs, and generated wastes. Regarding such concepts, the decision to move into greener alternatives has become inevitable. High performance thin-layer chromatography (HPTLC) has been drawing scientists' attention as a powerful greener candidate to replace HPLC. HPTLC-plates offer improved resolution and shorter analysis time through reduced silica particles' size. HPTLC's silica stationary phase is characterized mostly by the ability to be renewed and re-invented endlessly which is the core of the sustainability concept. In consequence, HPTLC is characterized by its ability for simultaneous analysis of many samples in a parallel manner, resulting in high sample throughput, and lower solvent and energy consumption per sample when compared with HPLC. Furthermore, the usage of HPTLC stead of HPLC could save environmental resources since no or few sample pre-treatments such as solid phase extraction or liquid-liquid extraction are required when compared with HPLC. Additionally, HPTLC is well suited to quantify several organic compound and profiling of their impurities as it could perfectly handle “dirty” samples without pre-treatment such that both polar and non-polar impurities can be detected even if sitting on the eluent front.The presented contribution is dedicated to spot the light on the opportunities existing for HPTLC as a promising sustainable alternative to HPLC in drugs' analysis and impurity profiling purposes. A model mixture containing Ebastine (EBS) and Phenylephrine hydrochloride (PHE), marketed as Ebast DC® tablets, was utilized in the study. Firstly, an HPTLC-method was developed and then validated for the simultaneous analysis and purity assessment of the named two drugs. Consequently, the obtained results were then compared with those of a previously reported HPLC-method from a green chemistry perspective.