Simultaneous Determination of Two Active Pharmaceuticals along with Synthetic Additives in Syrup Formulations Using RP-HPLC-PDA Method

Abstract

In this study, an RP-HPLC-PDA method for simultaneous determination of pseudoephedrine hydrochloride (PSE), guaifenesin (GUA), sodium benzoate (SB), sunset yellow (SSY) and methyl paraben (MP) in syrup formulations was developed and validated. The mobile phase was phosphate buffer solution and acetonitrile mixture (85:15 v/v) at pH 6.4 in isocratic elution mode. The flow rate was 1.5 mL/min and detections were recorded by a PDA detector at 210, 220, 235, and 254 nm. All the active components and synthetic additives were eluted with mean retention times of 1.1, 1.5, 2.6, 4.6, and 5.7 min for SB, SSY, GUA, PSE, and MP, respectively. Afterwards, the validated method was successfully applied to the determination of SB, SSY, GUA, PSE, and MP in two commercial syrup samples. Hence, the developed method can be applied for the routine quality control analysis of both the studied drugs and synthetic additives.