Simultaneous liquid chromatographic determination of ebastine with two sympathomimetic drugs using a monolithic column

Abstract

Ebastine (EBS) has been assayed in its laboratory-prepared co-formulated tablets with either pseudoephedrine hydrochloride (PSU) or phenylephrine hydrochloride (PHR) using isocratic reversedphase chromatography. Separation was conducted using a 50mm × 4.6mm i.d., Chromolith® SpeedROD RP-18 end-capped column at ambient temperature. A mobile phase composed of water:acetonitrile in a ratio of 25:75 having a pH of 3.2, has been utilized at 1 mL/min with UV detection at 254 nm for both EBS and PSU and 274 nm for PHR which in turn increased the sensitivity of the proposed method significantly. Symmetric well-separated peaks resulted in a short chromatographic run; <5 min. The proposed method was subjected to detailed validation procedures and proved to be highly sensitive as shown from limit of quantification values which were 4.7, 39.4 and 10.2 μg/mL for EBS, PSU and PHR, respectively. The proposed method was used to analyze EBS in its laboratory-prepared co-formulated tablets; the obtained results were comparable to those resulting from the reference method.