Assessment of drug content uniformity of atropine sulfate triturate by liquid chromatography–tandem mass spectrometry X-ray powder diffraction and Raman chemical imaging

摘要

BackgroundAtropine sulfate is an anticholinergic agent for treatment of hypertrophic pyloric stenosis and is orally administrated as a triturate with lactose hydrate. Because of the low safety margin of atropine sulfate, triturate uniformity is a key safety factor. In this study, we assessed the uniformity of atropine sulfate in 1000-fold triturates prepared by wet mixing and dry mixing methods and discussed the cause of the difference in uniformity between two preparation methods.