Determination of Chlorpheniramine Maleate in the Presence of Tartrazine in Tablets Using High Performance Thin Layer Chromatography

Tartrazine is a colouring substance suspected to interfere with the determination of chlorpheniramine maleate (CPM) in tablet analyzed using USP39/NF34 method. The purpose of this study, therefore, was to separate tartrazine using High Performance Thin Layer Chromatography (HPTLC), and five microliters of samples with standard solution were spotted on the HPTLC plate of silica gel 60 F254. Furthermore, the result showed the ability of a mixture of isopropanol and NH4OH (24:6 v/v) as a mobile phase to separate tartrazine and maleic acid from chlorpheniramine, with Rs value of > 1.5. Meanwhile, the HPTLC validation method used were as follows: linearity of CPM in the range concentration of 400-5000 ppm was 0.998, while the accuracy and precision was 99.93 % and 3.50%, respectively. In addition, drug determination in the registered tablets was conducted using the proposed technique, which showed that concentrations in samples met the specifications as stated in USP39/NF34 monography.