Simultaneous Determination of Acetaminophen and Synthetic Color(s) by Derivative Spectroscopy in Syrup Formulations and Validation by HPLC: Exposure Risk of Colors to Children
| Autor: | Shanya Das Rastogi, Mukul Das, Sumita Dixit, Anurag Tripathi |
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| Rok vydání: | 2014 |
| Předmět: |
Risk
Acceptable daily intake Calibration curve Chemistry Pharmaceutical Pharmaceutical Science Excipient Derivative Aquatic Science Pharmaceutical formulation Pediatrics Excipients chemistry.chemical_compound Drug Discovery medicine Humans Child Coloring Agents Chromatography High Pressure Liquid Ecology Evolution Behavior and Systematics Acetaminophen Detection limit Chromatography Ecology Chemistry Spectrum Analysis General Medicine Erythrosine Sunset Yellow FCF Calibration Food Additives Agronomy and Crop Science Research Article medicine.drug |
| Zdroj: | AAPS PharmSciTech. 16:505-517 |
| ISSN: | 1530-9932 |
| DOI: | 10.1208/s12249-014-0228-2 |
| Popis: | Color additives are used in pediatric syrup formulations as an excipient; though not pre-requisite, but pediatric syrup formulations are normally colored. An attempt has been made to measure simultaneously the single drug, acetaminophen (AT), along with the colors, carmoisine (CA), erythrosine (ET), and sunset yellow FCF (SSY) added in it by three derivative spectroscopy methods namely, 1st order, ratio, and differential derivative methods. Moreover, evaluation has been made for the exposure assessment of the colors added as excipient because some colors have been reported to cause allergic reactions and hypersensitivity in children. The present methods provide simple, accurate, and reproducible quantitative determination of the drug, AT, along with the color in synthetic mixtures and commercial drug formulations without any interference. The limit of detection varied from 0.0001-0.31 μg/ml while limit of quantification ranged from 0.002-1.04 μg/ml in all the three methods. The calibration curve of all the three derivative methods exhibited good linear relationship with excellent regression coefficients (0.9986-1.000). Both intra-day and inter-day precisions showed %RSD value less than 2% while the percentage recovery was found between 96.8-103.8%. The sensitivity of the proposed methods is almost comparable to HPLC and thus, can be used for determination of drug AT, and color simultaneously in pharmaceutical formulation on routine basis. The present methods also showed that colors like SSY and ET are saturating more than 50% of acceptable daily intake (ADI) value which is alarming and needs to be considered for modification by regulatory authorities to safeguard the health of children. |
| Databáze: | OpenAIRE |
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