A Facile HPLC-PDA Method for Simultaneous Determination of Paracetamol, Methyl Paraben, Sunset Yellow, and Carmosine in Oral Suspensions

Abstract

In the present study, a simple, fast, and accurate HPLC-PDA method was developed for thesimultaneous determination of paracetamol (PAR), methylparaben (MP), sunset yellow (SSY)and carmoisine (CAR) in oral suspensions. The concentrations of colorants are less than withrespect to those of active ingredient and this variation makes process of analysis troublesome.In the developed HPLC method, efficient chromatographic separation was achieved usingreversed phase C18 column (4.6 mm x 150 mm x 5 μm particle size) and phosphate buffersolution (pH = 6.5)-acetonitrile mobile phase with a flow rate of 1.6 mL/min in the gradientmode. The eluents were monitored via a PDA detector at 300, 254 and 230 nm. The meanretention times of PAR, MP, SSY and CAR were found to be 2.15, 4.42, 1.58 and 3.81,respectively. The proposed method was validated in accordance with ICH guidelines and it wasseen that the method met all requirements in terms of linearity, precision, accuracy, andselectivity. The developed method was successfully applied for simultaneous determination ofthe studied compounds in two commercial oral suspension samples.