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A thin-layer chromatographic method combined with a sample preparation procedure has been developed for determination of Sunset Yellow (E110) and Amaranth (E123) synthetic dyes in different pharmaceutical powders. For an accurate separation of investigated dyes, different mobile phases were tested using silica gel G chromatographic plates. The dyes were analyzed using slit scanning densitometry with specific wavelength selection (λ=485 nm for E110 and λ=520nm for E123). Experimental results showed a very good linear correlation (R² > 0.9940) between area of colored spots and concentration of dyes in range of 4-20 μg/mL. In addition, low values of LOQ (0.29 μg/mL for E123 and 0.46 μg/mL for E110) and LOD (0.58 μg/mL for E123 and 0.92 μg/mL for E110) were obtained. The sample preparation step was focused on the quantitative desorption of dyes from starch based matrix and sugars removing. In the case of non soluble matrix, different extraction solvents and techniques were tested. The best results were obtained using ultrasounds assisted extraction (UAE) using the mixture of MeOH-NH3 (9:1 v/v) as extraction agent. In the case of water soluble samples, a purification step by ion-pair – solid phase extraction (IP-SPE) on C18 cartridges using hexadecyltrimethyl-ammonium bromide (CTAB) was developed. High recovery values (R%) and a good reproducibility (RSD) was obtained for E110 and E123 (99.27±3.73% and 98.84±1.17% respectively). The applicability of the developed method was assessed for Coldrex and Daleron Junior pharmaceutical powders. The obtained results (42.64±3.29mg/kg E110 and 218.86±10.73mg/kg E123 in Coldrex and 54.21±3.95mg/kg E110 in Daleron) showed that the proposed method is suitable for rapid routine analysis of synthetic dyes in pharmaceutical powders.

Keywords: pharmaceutical powders, food synthetic colorants, sample preparation, TLC-densitometry