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A novel USP-HPTLC protocol compliant method for the simultaneous quantification of E-102, E-124, and E-133 azo dyes in consumer goods
JPC - Journal of Planar Chromatography - Modern TLC ( IF 1.6 ) Pub Date : 2020-08-06 , DOI: 10.1007/s00764-020-00038-9
Shrikrishna Madhukar Nandanwadkar , Vinayak Mastiholimath

Azo dyes, in spite of being additives, are indeed an integral constituent of consumer goods with bio-therapeutic values. The addition of dyes is for consumer compliance which lends a sense of pleasing aesthetics to the consumption ready product, “a kind of placebo effect”. Consequently, imperative need of the hour is felt to quantify such azo dyes due to complications like skin allergic reactions, genotoxicity, and ADHD symptoms leading to carcinogenicity in the long run, by apt analytical technique. In the proposed research, a pivotal USP-HPTLC compliant, validated, digitized method with multiple wavelength detection using TLC silica gel 60 F254 aluminum plates is developed. Mobile phase comprising of n-butanol–isopropanol–25% ammonia (GR grade)–water (65:20:10:5, v/v) has been put to task and subjected to spectro-densitometric scan for their simultaneous screening and quantification. Validation was done as per ICH and US FDA guidelines incorporating the latest 21 CFR approved, digital image CAMAG visionCATS software. The results revealed that the proposed method was highly sensitive with good linear relationship R = 99.999% and RSD of 0.456%. Thus, the method may be employed as standard quality control tool in consumer goods for characterization of azo dyes, which are still in the spectrum of doubt especially given the opaque data that surfaces on their safety profiles.



中文翻译:

一种符合USP-HPTLC协议的新颖方法,可同时定量消费品中的E-102,E-124和E-133偶氮染料

偶氮染料尽管是添加剂,但确实是具有生物治疗价值的消费品的组成部分。染料的添加符合消费者的要求,给即食型产品带来了一种令人愉悦的美感,即“一种安慰剂效应”。因此,通过适当的分析技术,迫切需要一个小时来量化由于诸如皮肤过敏反应,遗传毒性和导致长期致癌性的ADHD症状等并发症所导致的此类偶氮染料。在提出的研究中,开发了一种关键的USP-HPTLC兼容,经过验证的数字化方法,该方法使用TLC硅胶60 F 254铝板进行多波长检测。流动相由丁醇-异丙醇-25%氨水(GR级)-水组成(65:20:10:5,v / v)已投入使用,并进行了分光光度法扫描,以便同时进行筛选和定量。验证是根据ICH和美国FDA准则进行的,其中纳入了最新的21 CFR批准的数字图像CAMAG visionCATS软件。结果表明,该方法灵敏度高,线性关系R  = 99.999%,RSD为0.456%。因此,该方法可以用作消费品中用于表征偶氮染料特征的标准质量控制工具,偶氮染料仍然在可疑范围内,特别是考虑到在其安全曲线上浮现的不透明数据。

更新日期:2020-08-06
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