ABSTRACT:
Inulin is a representative of the class of soluble dietary fibers. One of the stated methods for identification of substances in the monograph “Inulin” of the British Pharmacopoeia 2010 (??) is the method of thin-layer chromatography (TLC), in the State Pharmacopoeia of Ukraine (SPhU) the method of TLC for identification of plant active pharmaceutical ingredients (API) of inulin is absent. The Pharmacopoeia provides only quality requirements of such monosaccharides as “Fructose”, “Anhydrous glucose”, “Glucose, monohydrate”, “Anhydrous lactose”, “Lactose monohydrate”. The experimental studies were conducted using nine herbal substances of inulin obtained from plant sources such as chicory, Jerusalem artichoke and agave and two standard substances of inulin with chicory and dahlia. Identification and determination of related impurities of plant API of inulin using TLC were performed according to the method of the monograph “Inulin” of the BP and the method of determination of monosaccharides given in the SPhU. The optimal conditions for the chromatographic determination have been chosen; validation of the method using indicators of specificity, robustness and precision has been conducted. The validated method for analysis of plant API of inulin using TLC has been proposed to be included into the draft for the monograph “Inulin” of the SPhU in the sections “Identification” and “Test for purity”.