Abstract
Abstract Gas chromatographic methods have been developed for the determination of doxepin as the sum of the resolved E and Z isomers, 4 doxepin-related compounds, and organic volatile impurities in drug raw material. Minimum quantifiable amounts of the related compounds in raw materials are less than 0.05%. A method for assay of doxepin, as the total of the E and Z isomers, in capsules was also developed; relative standard deviation is less than 1% for the drug assay. Eleven raw material and 18 capsule samples were examined. No drug-related compounds or U.S. Pharmacopeia- or European Pharmacopeia-limited organic volatile impurities were detected in any of the samples.
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