The study of degradation products of chlorpromazin hydrochloride by the method of liquid-mass spectroscopy in drugs for injection

Abstract

The analysis of model samples of the drug Aminazin has been performed, its active substance is chlorpromazine hydrochloride. These model solutions were subjected to sterilization with previous exposure at room temperature. It has been found that depending on duration of the exposure during sterilization the degradation of the drug occurs in two possible ways – with formation of opalescence or without it. The schemes of degradation with formation of either one product – chlorpromazine sulfoxide, or some products – chlorpromazine sulfoxide, chlorpromazine N-oxide, nor-chlorpromazine and others have been proposed. It has been found that opalescence of solutions is caused by formation of degradation products – chlorpromazine N-oxide and nor-chlorpromazine that are slightly soluble in water. The analysis of model samples was performed using the liquid chromatography/ mass spectrometry methods developed by the authors. In the course of analysis the molecular weights corresponding to the abovementioned products were obtained. Therefore, the experimental confirmation of the schemes of degradation proposed has been obtained. As the result of the research conducted the chromatographic method for detection of impurities using liquid chromatography/mass spectrometry has been developed, and the main ways of degradation of chlorpromazine hydrochloride in aqueous solutions have been determined. According to the result of the research the recommendations to the manufacturing process have been developed, and measures for optimizing the composition of the drug have been proposed.