A comparison was made of various methods which could be utiIized to determine quantitatively various medicinal amines used in a pressurized dosage form. The medicinal amines investigated during this study were atropine N.F., butacaine, ephedrine (anhydrous) N.F., tuaminoheptane, and propylhexedrine U.S.P. The conditions necessary for the chromatographic analysis were established initially using liquid samples of the medicinal amines dissolved in acetone, nitrobenzene, ethanol, and/or chloroform. Once these conditions were established, the aerosol formulation containing the medicinal amine was analyzed by gas chromatography. A procedure for sampling the aerosol was developed, so that those medicinal aerosol products containing amines also could be analyzed by several existing methods of analysis. A titrimetric method was used for each aerosol as a means of comparison for the gas chromatographic analysis. Atropine and butacaine aerosols could not be determined by gas chromatogra hy. Tuaminoheptane and propylhexedrine were assayed by gas chromatography f)rom a nitrobenzene solution, while e hedrine was assayed from an acetone solution. The results of this investigation in&cate the effectiveness of these two methods and show their application to the analysis of aerosol products.
AS CHROMATOGRAPHY has emerged as an G effective analytical tool for the quantitative determination of many medicinal substances (1-6). Fales and Pisano investigated biologically active amines, such as histamine, serotonin, and synephrine ( 7), through the use of gas chromatography. Separation and identification of sympathomimetic amines was the area of study for Brochmann-Hanssen and Svendsen (8). It was possible to identify several of these amines directly; however, in closely related compounds. derivatives had to be synthesized to effect separation. Ephedrine and pseudoephedrine were treated in this manner.
Porush et al. (9, 10) reported methods concerned with the analysis of various aerosol products. Several of the physical testing methods for aerosols, such as particle size and the analytical control procedures necessary in the production of aerosols, were investigated.
The purpose of this investigation was to devise an analytical procedure by which aerosols containing certain medicinal amines could be analyzed by conventional methods as well as gdS chromatography (11, 12). Gas chromatography was chosen as the agent for the analysis of these amines because of its ability for separation and identification. Until now, this separation took