Micelle Mediated – Cloud Point Extraction and Colorimetric Estimation of Sunset Yellow in Pharmaceutical Dosage Forms

ISSN: 2582-3353 Abstract: Sunset Yellow (SY) is a widely used pharmaceutical excipient for coloring the dosage forms. SY was efficiently extracted from selected liquid dosage forms using Brij 98 as a non-ionic surfactant in Micelle MediatedCloud Point Extraction (MM-CPE) method. Simple, accurate, and precise colorimetric methods like the calibration curve method and single point standardization method were developed and validated for the quantification of SY in liquid dosage forms. MM-CPE method was found to be highly efficient with good recovery rates for SY in samples and optimized for parameters like pH, the effect of salt, surfactant concentration, incubation time, and temperature. The colorimetric method showed good linearity from 3-18 μg/ml (R2=0.9995) for SY at absorption maxima of 482nm. The method was found to be precise (%RSD <2) and accurate (±10% limit). The assay values for the samples Ascoril (5ml) and P-125 drops (1 ml) were found to be 0.05 and 0.671 mg for the calibration curve method and 0.051 & 0.675 mg for the single point standardization method respectively. The developed methods were validated as per International council for Harmonisation (ICH) guidelines. The content of SY obtained is then compared with the allowable daily intake (ADI) value referred by European Union (EU) and World Health Organisation/Food and Agriculture Organisation (WHO/FAO) [0-4 mg/kg/b.w.]. The level of SY in sample dosage forms was par below the ADI limits and considered to be safe.