Оptimization of HPLC analysis conditions for risperidone and its decomposition products

Abstract

The purpose of this study is optimization of HPLC analysis conditions for risperidone and its decomposition products for the development of quantitative analysis for prolonged medicinal forms, and application of the mobile phase based on volatile, transparent in the short wavelength ultraviolet region of the spectrum components to approach the way to unify the chromatography analysis.

We optimized conditions for separation of risperidone and its decomposition products in reversed-phase system. We compared the retention time received for degradation products at different pH of the mobile phase with the data from literature, and the assumption is made about the chemical nature of the main product of decomposition of risperidone in the presence of hydrogen peroxide. We showed the possibilities of use of mobile phase containing water, acetonitrile, perchloric acid and ammonia to optimise the separation of peaks of the test system. We determined kinetic parameters for risperidone decomposition in the presence of hydrogen peroxide. We have studied for the first time the effect of acetonitrile and dimethyl sulfoxide on the rate of risperidone decomposition in the presence of hydrogen peroxide in the aqueous-organic solution. We showed that organic solvents accelerate the degradation due to the changed dielectric constant of the medium. The effect of dimethyl sulfoxide is much weaker, because of its higher dielectric constant compared to acetonitrile, and ability to react with hydrogen peroxide