Enantioselective HPLC analysis of escitalopram oxalate and its impurities using a cellulose-based chiral stationary phase under normal- and green reversed-phase conditions |
| |
Authors: | Chiara Cantatore Paola Bertocchi Daniela De Orsi Alessia Panusa Roberto Cirilli |
| |
Affiliation: | Centro nazionale per il controllo e la valutazione dei farmaci, Istituto Superiore di Sanità, Rome, Italy |
| |
Abstract: | Normal-phase and reversed-phase high-performance liquid chromatography methods for the separation of the active pharmaceutical ingredient escitalopram from its (R)-enantiomer impurity have been developed on the cellulose-based Chiralcel OJ-H chiral stationary phase. Both methods share two features: they use ethanol as a cosolvent and are able to give a complete enantioseparation without interference from other associated chiral impurities. With the green eluent mixture ethanol–water–diethylammine 70:30:0.1 (v/v/v), the resolution between escitalopram and (R)-enantiomer was 2.09 at 30°C. The limits of quantification for the (S) and (R) enantiomers were 4.5 and 3.8 μg mL−1, respectively. |
| |
Keywords: | absolute configuration cellulose tris(4-methylbenzoate) citalopram escitalopram green high-performance liquid chromatography |
|