Determination of Food Colorings in Pharmaceutical Preparations and Food Additives by a Validated HPLC Method Betül Esen

Esen B., Oymak T., Dural E.

International Journal of Scientific & Engineering Research, vol.9, no.8, pp.72-77, 2018 (Peer-Reviewed Journal)


Abstract— Synthetic azo dyestuffs are preferred in many products today because synthetic dyes are more resistant to environmental

factors and their production is relatively easy and cheap. Despite their commercial advantages, they have very important toxi cological risks

to its consumers. Tartrazine (E102), one of the most commonly used yellow food dye, is a synthetic lemon yellow azo dye used as a food

coloring. Sunset yellow (E110) a petroleum petroleum-derived orange azo dye, also known as yellow dye #6, is used to give foods an orange orange-yellow

color. Both food dyes have serious toxicological risks, that are mutagenic and carcinogenic. For this reason, it is very important that the

measurement of quantities in food products and pharmaceutical preparations by a fast, reliable and sensitive method. The aim of this

study, developed and also validated a new high high-performanc e liquid chromatography (HPLC) method equipped with diode array detector

(DAD) which was simultaneous determination for tartrazine and sunset yellow in pharmaceutical preparations and food supplements.

The chromatographic separation was carried out a reverserse-phase C18 analytical column, 4.6 mm x 250 mm, 5 µm particle size, at 40°C.

The mobile phase prepared as a mixture of pH 4 oxalate buffer, methanol, water (7:2:1, v/v) was isocratically applied to the column at 1

mL/min flow and, diode array detector wa s set at 432 nm and 480 nm for the determination of tartrazine and sunset yellow, respectively.

The samples were loaded into the HPLC as a 20 μL.

Total analysis time for simultaneous determination was below 6 min. The linear range for tartrazine and sunset yellow were between 0.2

and 20 µg/mL. Quantification limits of tartrazine and sunset yellow were 0.07 µg/mL and 0.19 µg/mL, respectively. Precision o f the method

for tartrazine sunset yellow were 4.0% and 7.1%, respectively. Recovery values in pharmaceutical samples which applied at 1, 2 and 5

µg/mL were found to be range from 87.7% to 104.3%. The proposed method shows excellent sensitivity, selectivity, and precision and has

been satisfactorily applied for the determination of tartrazine and sunset yellow in a variety of total 12 real pharmaceutical preparations the

and food supplements. This method applicable for routine food dyes monitoring especially in food analysis or in toxicology reference


Index Terms— Tartrazine, Sunset yellow, HP LC, DAD, Validation, Pharmaceutical preparation, Food additives