A novel USP-HPTLC protocol compliant method for the simultaneous quantification of E-102, E-124, and E-133 azo dyes in c
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IGINAL RESEARCH PAPER
A novel USP-HPTLC protocol compliant method for the simultaneous quantification of E-102, E-124, and E-133 azo dyes in consumer goods Shrikrishna Madhukar Nandanwadkar 1 & Vinayak Mastiholimath 2 Received: 10 April 2020 / Accepted: 22 June 2020 # Akadémiai Kiadó, Budapest, Hungary 2020
Abstract 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. Keywords Azo dyes . Consumer goods . USP-HPTLC . ICH . 21 CFR
Abbreviations Ng Nanograms LOD Limit of detection LOQ Limit of quantification HPTLC High-performance thin-layer chromatography Nm Nanometers μg/mL Microgram/milliliters ADHD Attention deficit hyperactivity syndrome ICH International Conference on Harmonization Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00764-020-00038-9) contains supplementary material, which is available to authorized users. * Shrikrishna Madhukar Nandanwadkar [email protected] 1
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CFR US-FDA EFSA FSSAI GIT WHO FAO MS HPLC GMP GLP RH mg EP USP RF
Code of Federal Regulations United States Food and Drug Administration European Food Safety Authority Food Safety and Standards Authority of India Gastrointestinal tract World Health Organization Food and Agricultural Organization Mass spectrometry High-performance liquid chromatography Good manufacturing practices Good laboratory practices Relative humidity Milligrams European Pharmacopoeia United States Pharmacopeia Retardation factor/retention factor
Department of Pharmaceutical Quality Assurance, KLE College of Pharmacy, KLE Academy of Higher Education and Research, Nehru Nagar, Belagavi, Belgaum, Karnataka 590-010, India
1 Introduction
Department of Pharmaceutics, KLE College of Pharmacy (A constitu
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