Green micellar liquid chromatographic method for simultaneous determination of antihistaminic drugs tripelennamine hydrochloride and diphenhydramine in pharmaceutical gel.

Abstract

A new green micellar liquid chromatographic method has been developed and validated for the simultaneous determination of diphenhydramine (DPH) and tripelennamine hydrochloride (TRP) using a micellar mobile phase consisting of 1mM Tween 20 in phosphate buffer pH 4:isopropanol (85:15, %v/v). The method was linear in the range of 4-150 and 5-120μg/mL for TRP and DPH, respectively. The method was successfully applied for the simultaneous determination of DPH and TRP in a laboratory-prepared gel containing all possible excipients with mean percent recoveries±standard deviation of 100.346±1.265 and 100.754±1.117 for TRP and DPH, respectively. The method was validated according to the International Conference on Harmonization guidelines. The method is confirmed to have excellent greenness.