Photodegradation assessment of amisulpride, doxepin, haloperidol, risperidone, venlafaxine, and zopiclone in bulk drug and in the presence of excipients

Abstract

Abstract Photostability of amisulpride, doxepin, haloperidol, risperidone, venlafaxine, and zopiclone in APIs and powdered tablets during exposure to UVA irradiation was studied. In order to evaluate the photodegradation process an ultrahigh performance liquid chromatography method coupled with tandem mass spectrometry (UHPLC-MS/MS) was developed and validated. It was found that the photodegradation of the studied compounds depends on the type of drug and co-existing excipients. Different percentage of photodegradation of the studied drugs was observed, and therefore amisulpride decomposed at 2.63% in bulk drug and at 5.74% in pharmaceutical preparation, doxepin: 29% and 72.38%, haloperidol: 3.71% and 26.20%, risperidone: 7.13% and 12.86%, venlafaxine: 38.59% and 4.22%, zopiclone: 18.62% and 31.42% respectively, after 114 days of UVA irradiation. In addition, kinetic evaluation of the photodegradation process was performed by determining the order of reaction, reaction rate constant k and time t0.1 and t0.5. The photodegradation products of studied drugs were identified, and their fragmentation pathways, derived from MS/MS data, were proposed. The photostability testing is an integral part of the drug stability assessment to ensure quality, efficacy and safety of the formulated products during manufacturing process, storage as well as normal use. Graphic abstract