Modification of the hplc method of confirming the content of sorbitol and permissible or unacceptable impurities in the composition of a biological active substance

Abstract

Sorbitol (glucitol) is an organic substance that belongs to six-atom alcohols. According to the chemical nomenclature, IUPAC is called (2S,3R,4R,5R)-hexane-1,2,3,4,5,6- hexol. Sorbitol is found in natural sources (plants, algae), is used as a sweetener in the food industry, as an additional substance in pharmaceutical compositions. It is used as a non-stimulating

laxative in the form of an oral suspension or enema. Sorbitol is obtained by hydrogenation of D- glucose. Quite often, sorbitol is used in combination with other medicinal substances. As a reactive

alcohol, sorbitol can enter into a chemical interaction with other components of the mixture, which will lead to the formation of additional substances, the content of which is not regulated by the Pharmacopoeia. The development and adaptation of chromatographic conditions by the HPLC method of the sorbitol substance is an urgent task of pharmaceutical analysis for the detection of unspecified impurities and unacceptable substances not declared by the manufacturer of the substance