Abstract

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

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