Ion Exchange Method for the Separation and Spectrophotometric Determination of Some Sympathomimetic Amines, Antihistamines, and Phenothiazines in Pharmaceuticals

An ion exchange procedure has been developed for the separation and quantitative analysis of 32 drugs in various combinations: (a) promethazine HCl with codeine phosphate and potassium guaiacolsulfonate; (b) phenylephrine or phenylpropanolamine HCl with (1) dextromethorphan HBr, potassium guaiacolsulfonate, chlorpheniramine maleate, and/or pyrilamine maleate; (2) dextromethorphan HBr, glyceryl guaiacolate, chlorpheniramine maleate, and/or pyrilamine maleate; (3) dextromethorphan HBr and potassium guaiacolsulfonate; (4) dextromethorphan HBr and glyceryl guaiacolate; (5) dextromethorphan HBr and antihistamine; (6) antihistamine and glyceryl guaiacolsulfonate; (7) antihistamine and potassium guaiacolsulfonate; (8) dextromethorphan HBr; (9) glyceryl guaiacolate; (10) potassium guaiacolsulfonate; (c) promethazine HCl with (1) codeine phosphate or (2) phenylephrine HCl; (d) codeine phosphate and potassium guaiacolsulfonate; (e) chlorpromazine HCl, promazine HCl, or promethazine HCl; (f) phenylephrine HCl; (g) codeine phosphate; (h) perphenazine HCl alone or with amitriptyline HCl; (i) ephedrine sulfate with phenobarbital, theophylline, and glyceryl guaiacolate; (j) l-epinephrine bitartrate alone or with antihistamine; (k) procaine HCl, procainamide HCl, procaine isobutyrate, or tetracaine HCl; (l) quinine sulfate with aminophylline; (m) dextromethorphan HBr with (1) terpin hydrate; (2) antihistamine; (3) potassium guaiacolsulfonate; (4) glyceryl guaiacolate; and (n) atropine sulfate or honiatropine methylbromide. The 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 HCl and are determined by 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 HCl and determined by I’V absorption. Average recoveries ranged from 98.6 to 101% in the absence of excipients and 95.8 to 102% with excipients present. The method is recommended for collaborative study.