Development and validation of a stability-indicating high performance liquid chromatographic assay for determination of cariprazine in bulk form and in drug product

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 & REG; C18 column (5 & mu;m, 250 x 4.6 mm) and a mobile phase consisting of acetonitrile-potassium dihy-drogen orthophosphate buffer (pH 4; 50 mM) (30:70, v/v), at a flow rate of 1 ml min-1 and UV detection at 248 nm. The column was maintained at 25 degrees C and an injection volume of 20 & mu;L 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 con-ditions 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. & COPY; 2022 Acad & PRIME;emie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.