VALIDATION OF A MICELLAR ELECTROKINETIC CAPILLARY CHROMATOGRAPHY (MECC) METHOD FOR THE DETERMINATION OF P-TOLUENESULFONIC ACID IMPURITY IN A PHARMACEUTICAL INTERMEDIATE

摘要

Micellar Electrokinetic capillary chromatography (MECC) has been employed for the quantitation of p-toluenesulphonic acid (pTSA) impurity levels in 5-fluoro-3-[3-(1-piperazinyl)-Propyl]-1H-indole (EMS 180317-01) a key intermediate used in the synthesis of a novel antidepressant drug candidate EMS 181101-02. The MECC method demonstrated good selectivity, precision, accuracy, linearity, limit of detection and quantitation. MECC of small ionic or polar molecules offers a useful alternative to ion chromatography, ion pair chromatography and RP-HPLC.