Determination of sulphonated quinophthalones in Quinoline Yellow and its lakes using high-performance liquid chromatography.

Quinoline Yellow (QY, Colour Index No. 47005) is internationally used as a colour additive in foods, drugs, and cosmetics. The manufacture of QY requires sulphonating quinophthalone, and depending on the degree of sulphonation, various forms of QY result, containing different proportions of quinophthalone mono-, di-, and trisulfonic acid sodium salts (monoSA, diSA, and triSA, respectively). Regulations on the specific composition and uses of QY differ across countries with associated differences in names for QY. The QY form certified for use in the U.S. in drugs and cosmetics is known as D&C Yellow No. 10 (Y10). The Code of Federal Regulations (CFR) specifies that Y10 and its lakes consist of predominantly monoSA's, the sum of whose levels is >= 75%, and that the sum level of diSA's is <= 15%, with one of them (6MODIFIER LETTER PRIME8'diSA) at <= 3%. The present work reports the development of an HPLC method for determining those CFR-specified values and the level of a non-CFR-specified component, 6MODIFIER LETTER PRIME8'5triSA. The selected analytes, 6'SA, 6MODIFIER LETTER PRIME5diSA, 6MODIFIER LETTER PRIME8'diSA, and 6MODIFIER LETTER PRIME8'5triSA, were quantified by using five-point-calibration curves (R-2 > 0.999) with data-point ranges of 9.96-96.53%, 0.54-21.69%, 0.10-5.00%, and 0.11-5.53% by weight, respectively. The method was found to be precise (relative standard deviation values, 0.55-0.80%) and accurate (recovery values, 91.07-99.45%). LOD and LOQ values, respectively, were as follows: 1.23 and 3.70%, 6'SA; 0.42 and 1.26%, 6MODIFIER LETTER PRIME5diSA; 0.11 and 0.34%, 6MODIFIER LETTER PRIME8'diSA; and 0.01 and 0.04%, 6MODIFIER LETTER PRIME8'5triSA. The HPLC method was applied successfully to the analysis of 20 Y10 and eight Y10 lake samples. It can be extended to other QY forms such as E104 and Yellow 203 because it enables analysis of 6MODIFIER LETTER PRIME8'5triSA. This paper also addresses the implications of the varying structure depictions and CAS numbers of the QY components that are due to the existence of three tautomeric forms of quinophthalone.