Collaborative study of an ion exchange method for the chromatographic separation of mixtures containing expectorants, sympathomimetic amines, antihistamines, or phenothiazine in pharmaceuticals
Smith, D.J.
Journal - Association of Official Analytical Chemists 57(3): 741-746
1974
ISSN/ISBN: 0004-5756 PMID: 4151588 Document Number: 78056
An ion exchange chromatographic method has been applied to the determination of 9 drugs in various dosage forms, alone or in combination: chlorpheniramine maleate, codeine phosphate, dextromethorphan. HBr, glyceryl guaiacolate, phenylephrine. HCI, phenylpropanolamine . HCI, potassium guaiacolsulfonate, promethazine. HO, and pyrilamine maleate. Nitrogenous bases are separated from the excipients by retention on a sulfonated polystyrene resin column. These basic compounds are eluted from the column with the appropriate concentration of HCI and are determined by ultraviolet (UV) absorption. The organic acids are retained on the quaternary ammonium anion resin. The acidic compounds are eluted from the columns with the appropriate concentration of HQ and determined by UV absorption. Average recoveries and standard deviations for the 9 drug ingredients in 3 simulated combinations ranged from a low of 93.2±4.03% (phenylpropanolamine . HCI) to a high of 98.8±4.8% (codeine phosphate), for 6 unknown samples per collaborator. Comparable values were reported for 2 commercial sirups collaboratively studied. The method has been adopted as official first action for the following compounds: (a) promethazine . HCI, phenylephrine. HCI or phenylpropanolamine. HCI (except in tablets or powders), and potassium guaiacolsulfonate; (b) promethazine. HCI codeine phosphate, and potassium guaiacolsulfonate; (c) phenylephrine. HCI or phenylpropanolamine. HQ (except in tablets or powders), dextromethorphan.HBr (except in sirups), potassium guaiacolsulfonate, and pyrilamine maleate; and (d) phenylephrine. HCI or phenylpropanolamine. HCI (except in tablets or powders), dextromethorphan. HBr (except in sirups), glyceryl guaiacolate, and pyrilamine maleate.