Study on dissolution behaviour and quantification of gallic acid as a chemical marker in Kacip Fatimah herbal medicinal products

Abstract

Dissolution behaviour of active ingredients has an important effect on their pharmacological function. In reality, predicting their bioavailability is considered to be one of the most critical quality control tests. In this study dissolution behaviour was carried out using model independent included fit factors which comply with the FDA guidelines. The parameters of test ratio are the fit factors which include difference factor (f1) and similar factor (f2). These parameters were employed to compare in-vitro dissolution behaviour which were tested using different media; 0.1 M HCl, 30% EtOH, acetate buffer (pH 4.8) and phosphate buffer pH 6.8. Three brands of Kacip Fatimah (I,II,III) were compared and brands V is a pure Kacip Fatimah used as a benchmark. The active ingredients namely galic acid in all samples was also quantified using a reverse-phase HPLC. Results obtained indicate that the dissolution efficiency for active ingredients for all brands were not significantly different however, gallic acid in all brands showed the highest solubility in 0.1 M HCl compared to the other three media used. Meanwhile, product I showed the highest amount of galic acid released compared to product II and product III. Using fit factors, only brands 1 and brand V showed similarity in results. Contents of the Gallic acid for brand I and brand V analysed via HPLC were the highest. Both results from in-vitro dissolution and HPLC test could be applied for quality control of gallic acid for Kacip Fatimah as herbal medicinal products available in markets.