Separation and determination of sorbitol and xylitol in multi-component pharmaceutical formulations by capillary isotachophoresis. 1998

M Pospísilová, and M Polásek, and V Jokl
Department of Analytical Chemistry, Faculty of Pharmacy, Charles University, Heyrovského, Czech Republic. pospisim@faf.cuni.cz

Pharmaceutically important polyhydric alcohols sorbitol (SO) and xylitol (XY) are efficiently separated and determined by analytical capillary isotachophoresis (ITP) with conductometric detection. The on-column complex-formation equilibria between the polyols and boric acid are utilized--the terminating borate ion acts as the complexing agent. The ITP operational system used consists of 10 mM HCl + 20 mM imidazole (LE, pH 7.0) and 20 mM boric acid (TE, pH 8.0). The effective mobilities of the borated SO and XY are 8.3 x 10(-9) m2 V-1 s-1 and 7.4 x 10(-9) m2 V-1 s-1, respectively. The ITP analysis is performed with the driving and detection currents of 50 microA (for 700 s) and 20 microA, respectively. The calibration graphs are rectilinear in the range 25-250 mg l-1 of SO and 50 to 500 mg l-1 of XY. The method is applied to the simultaneous assay of SO and XY in three mass-produced multi-component infusion solutions. Favourable values of the method validation parameters obtained confirm the suitability of the proposed ITP method for the quality control of pharmaceuticals.

UI MeSH Term Description Entries
D011108 Polymers Compounds formed by the joining of smaller, usually repeating, units linked by covalent bonds. These compounds often form large macromolecules (e.g., BIOPOLYMERS; PLASTICS). Polymer
D001888 Boric Acids Inorganic and organic derivatives of boric acid either B(OH)3 or, preferably H3BO3. Acids, Boric
D002138 Calibration Determination, by measurement or comparison with a standard, of the correct value of each scale reading on a meter or other measuring instrument; or determination of the settings of a control device that correspond to particular values of voltage, current, frequency or other output. Calibrations
D002241 Carbohydrates A class of organic compounds composed of carbon, hydrogen, and oxygen in a ratio of Cn(H2O)n. The largest class of organic compounds, including STARCH; GLYCOGEN; CELLULOSE; POLYSACCHARIDES; and simple MONOSACCHARIDES. Carbohydrate
D002626 Chemistry, Pharmaceutical Chemistry dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use. Medicinal Chemistry,Chemistry, Pharmaceutic,Pharmaceutic Chemistry,Pharmaceutical Chemistry,Chemistry, Medicinal
D004586 Electrophoresis An electrochemical process in which macromolecules or colloidal particles with a net electric charge migrate in a solution under the influence of an electric current. Electrophoreses
D012996 Solutions The homogeneous mixtures formed by the mixing of a solid, liquid, or gaseous substance (solute) with a liquid (the solvent), from which the dissolved substances can be recovered by physical processes. (From Grant & Hackh's Chemical Dictionary, 5th ed) Solution
D013012 Sorbitol A polyhydric alcohol with about half the sweetness of sucrose. Sorbitol occurs naturally and is also produced synthetically from glucose. It was formerly used as a diuretic and may still be used as a laxative and in irrigating solutions for some surgical procedures. It is also used in many manufacturing processes, as a pharmaceutical aid, and in several research applications. Glucitol,Medevac,Sorbilax,Yal,klysma Sorbit
D014993 Xylitol A five-carbon sugar alcohol derived from XYLOSE by reduction of the carbonyl group. It is as sweet as sucrose and used as a noncariogenic sweetener.
D017186 Titrimetry The determination of the concentration of a given component in solution (the analyte) by addition of a liquid reagent of known strength (the titrant) until an equivalence point is reached (when the reactants are present in stoichiometric proportions). Often an indicator is added to make the equivalence point visible (e.g., a change in color).

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