D&C Yellow No. 10 (Y10, Colour Index No. 47005) and its lakes, Y10L (Y10 precipitated onto an insoluble substratum, e.g., alumina, at 10-40% total color content), are U.S.-certified color additives used in drugs and cosmetics.Y10 is manufactured by condensing 2-methylquinoline (quinaldine) with phthalic anhydride. The condensation product, 2-(2'-quinolinyl)-1H-indene-1,3(2H)-dione (quinophthalone), is then sulfonated, and the resulting compounds are isolated as sodium salts. Depending on the extent of sulfonation, mixtures of mono-, di-, and trisulfonated quinophthalone components may result. Y10 contains mainly monosulfonated components, while a variant form of this dye, used in the European Union (E 104) and in Japan (Yellow 203) and other countries, contains mostly a mixture of the di-and trisulfonated isomers. Before Y10 and Y10L may be used, they are subject to batch certification by the U.S. Food and Drug Administration (FDA) to ensure compliance with specifications in the U.S. Code of Federal Regulations (CFR). The CFR specifies the permitted level of monosulfonated quinophthalones at “not less than 75%” and of the disulfonated quinophthalones at “not more than 15%” in Y10. The current method of analyzing the sulfonated quinophthalones for certification purposes involves a labor-intensive, multi-step, time-consuming procedure (6 hr per analysis) that includes thin-layer chromatography followed by spectrophotometric quantification. The present work reports the development of a fast (18 min per analysis), automated, simpler-to-implement HPLC method for the determination of mono-, di-, and trisulfonated quinophthalones in Y10 and its lakes. The method is intended for use in routine batch-certification analyses.

Determination of mono-, di-, and trisulfonated quinophthalones in the color additive D&C Yellow No. 10 (Quinoline Yellow) using high-performance liquid chromatography

255th National Meeting (2018)

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