|1.Department of Pharmaceutics and Pharmaceutical Microbiology, Faculty of Pharmaceutical Sciences, Usmanu Danfodiyo University, Sokoto.
2. Department of Pharmacognosy and EthnoPharmacy, Faculty of Pharmaceutical Sciences, Usmanu Danfodiyo University, Sokoto.
3.Department of Pharmaceutics and Pharmaceutical Microbiology, Faculty of Pharmacy, University of Maiduguri, Borno state.
Afr. J Pharm Res Dev; Volume 12(2): 157-163 ; 2020
Synthetic colourants currently in use in pharmaceutical formulations are only relatively safe as several studies have shown that they cause hypersensitivity and allergic reactions and many have even been banned due to their risk of carcinogenicity. This study was carried out to determine the stability of H. sabdariffa as colourants in paracetamol syrup formulation. The extract of the plants was extracted using ethanol. Physicochemical tests were carried out on the extract using standard method. Formulated Paracetamol syrup was coloured using a solution of 20 %w/v and 40 %w/v H. sabdariffa extract with amaranth as standard. Accelerated stability tests was carried out based on ICH guidelines at 75 % relative humidity and 40 oC. The absorbance for the drug stability tests was taken at 257nm. The results of the drug stability tests showed a general reduction in the concentration of paracetamol in the formulated syrups over time. There was generally a reduction in colorant concentration in formulated paracetamol syrups over time when exposed to light but with slightly higher concentration in amber coloured bottles as compared to plain bottles. Results of temperature stability tests showed a decrease in concentration of the colorant at 37 oC and 52 0C. In conclusion, the H. sabdariffa is suitable as colorants in paracetamol syrup formulations but their stability is affected by light and also slightly by temperature.
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KEYWORDS: Colorant, Hibiscus sabdariffa, Light, Paracetamol, Syrup and Temperature.