DETERMINATION OF INTERMEDIATES AND SUBSIDIARY COLORS IN THE COLOR ADDITIVE FD&C RED NO. 4 (PONCEAU SX) USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

Specifications in the U.S. Code of Federal Regulations for the color additive FD&C Red No. 4 (Color Index 14700) limit the levels of the intermediates, 5-amino-2,4-dimethyl-1-benzenesulfonic acid (AMBSA) and 4-hydroxy-1-naphthalenesulfonic acid (HNSA), and of subsidiary colors. The present study...

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Bibliographic Details
Published in:	Journal of liquid chromatography & related technologies Vol. 34; no. 2; pp. 106 - 115
Main Authors:	Vu, Nga T., Rickard, James D., Sullivan, Michael P., Richfield-Fratz, Naomi, Weisz, Adrian
Format:	Journal Article
Language:	English
Published:	Colchester Taylor & Francis Group 07-01-2011 Taylor & Francis
Subjects:	3-[(2,4-dimethyl-6-sulfophenyl)azo]-4-hydroxy-1-naphthalenesulfonic acid 4-hydroxy-1-naphthalenesulfonic acid 5-amino-2,4-dimethyl-1-benzenesulfonic acid Biological and medical sciences C.I. 14700 FD&C Red No. 4 Food additives Food industries Fundamental and applied biological sciences. Psychology General aspects High-speed countercurrent chromatography (HSCCC) HPLC Ponceau SX Food colorant Countercurrent chromatography Chemical analysis Purification Impurity Preparative chromatography Reaction product 3-[(2,4-dimethyl-6-sulfophenyl)azo]-4-hydroxy-1-naphthalenesulfonic acid HPLC chromatography Purity control High-speed countercurrent chromatography (HSCCC) FD&C Red No4 Ponceau SX Azo dye Quality control Reagents Isolation Diode array 4-hydroxy-1-naphthalenesulfonic acid By product 5-amino-2,4-dimethyl-1-benzenesulfonic acid, C.I14700 HPLC Quantitative analysis Ultraviolet visible spectrometry
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Summary:	Specifications in the U.S. Code of Federal Regulations for the color additive FD&C Red No. 4 (Color Index 14700) limit the levels of the intermediates, 5-amino-2,4-dimethyl-1-benzenesulfonic acid (AMBSA) and 4-hydroxy-1-naphthalenesulfonic acid (HNSA), and of subsidiary colors. The present study reports the development of a high-performance liquid chromatography (HPLC) method for the quantitative determination of these intermediates and subsidiary colors in one analysis. The most commonly-found subsidiary color, 3-[(2,4-dimethyl-6-sulfophenyl)azo]-4-hydroxy-1-naphthalenesulfonic acid (6SSC), is determined and is used as a secondary reference material to determine the quantities of other subsidiary colors present. High-speed countercurrent chromatography was used to obtain purified HNSA and 6SSC for use as reference materials. AMBSA, HNSA, and 6SSC were quantified by using five-point calibration curves with data points that ranged from 0.028-0.234%, 0.031-0.252%, and 0.113-2.036% by weight, respectively. The HPLC method is rapid (50 min for the total analysis cycle) and simple to implement. It was applied to the analysis of test portions from 23 lots of FD&C Red No. 4 submitted to the U.S. Food and Drug Administration (FDA) for certification and was later implemented by the FDA for routine batch certification of FD&C Red No. 4.
ISSN:	1082-6076 1520-572X
DOI:	10.1080/10826076.2010.526874