比色法による混合製剤中の塩酸フェニレフリンの定量

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Phenylephrine HCl (I) reacts with 4-aminoantipyrine and K3Fe(CN)6 in an alkaline medium buffered at pH 9 to give orange coloration. The chromogen produced extracted into chloroform gives an absorption maximum at 460 mμ. A new spectrophotometric method based on this color reaction has been established for the determination of (I) in pharmaceutical preparations. Influences of 45 compounds on the determination were examined, whereby those by sulpyrine, aminopyrine, isopropylantipyrine, acetaminophen, ethoxybenzamide, salicylate, theophylline, quinine HCl, ascorbic acid, taurine, etc. are eliminated by the extraction with chloroform in acidic medium. The procedure recommended is as follows. A sample {containing 50 mg of (I)} is taken in a separatory funnel. Ten milliliters of water and 10 ml of 0.1 N HCl are added, and interfering substances is extracted 3 times with 30 ml portions of chloroform. The aqueous solution is transfered into a 50 ml volometric flask and is diluted exactly to 50 ml with water. A 2 ml aliquot is taken into another 50 ml volumetric flask and made up to the mark with water. Two milliliters of this solution is transfered to a 25 ml glass-stoppered test tube, and 10 ml of 0.2 M borate buffer, 2 ml of 1% 4-aminoantipyrine solution, and 2 ml of 2% K3Fe (CN) 6 solution are added. After allowing to stand for 5 min., it is shaken with 10 ml of chloroform for 1 min. The separated chloroform layer is dried by shaking with 2 g of Na2SO4, and the absorbance is measured at 460 mμ (ET) against chloroform. At the same time, the absorbance of the standard solution (Es) is determined, and the amount of (I) is calculated by ET/ES.
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比色法による混合製剤中の塩酸フェニレフリンの定量

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