Validation of a Micellar Electrokinetic Capillary Chromatography (MECC) Method for the Determination of p-Toluenesulfonic Acid Impurity in a Pharmaceutical Intermediate

Abstract

Abstract Micellar Electrokinetic capillary chromatography (MECC) has been employed for the quantitation of ptoluenesulphonic acid (pTSA) impurity levels in 5-fluoro-3-[3-(1-piperazinyl)-Propyl]-1H-indole (BMS 180317–01) a key intermediate used in the synthesis of a novel antidepressant drug candidate BMS 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.