ABSTRACT
The aim of the present study is to develop a stability indicating high performance liquid chromatographic method for the determination of cariprazine in bulk substance and in drug product. The chromatographic separation was carried out using a Phenomenex Kinetex® C18 column (5µm, 250×4.6mm) and a mobile phase consisting of acetonitrile-potassium dihydrogen orthophosphate buffer (pH 4; 50mM) (30:70, v/v), at a flow rate of 1mlmin -1 and UV detection at 248nm. The column was maintained at 25°C and an injection volume of 20µL was used. Stress testing of cariprazine bulk substance and drug product was performed according to the International Conference on Harmonization (ICH) Q1A (R2) guideline. Various stress conditions were tested including acidic, alkaline and neutral hydrolysis, humidity, oxidation, dry heat and photolysis. A total of three degradation products (DPs) were formed. Among them two DPs were successfully characterized with the liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis.
