Development of chemometrically optimized capillary electrophoresis method for the determination of asenapine in pharmaceutical tablets

Asenapine is an antipsychotic drug approved as monotherapy and adjunctive therapy in schizophrenia and bipolar disorder diseases. A new capillary electrophoresis method was presented for the determination of asenapine, an atypical antipsychotic drug, in pharmaceuticals. During the studies, capillary with an inner diameter of 75 µm and an effective length of 40 cm (48 cm total length) was used. Box-Behnken design, an experimental design method, was used to investigate the effects of run buffer pH, run buffer concentration and applied potential on the separation of asenapine and granisetron (IS). The optimum conditions were phosphate buffer (15 mM, pH:3,1) with 25,7 kV voltage and 20°C capillary temperature. The method was validated according to ICH guideline. A good linearity was obtained in the concentration range of 0,27-6,4 µg/mL with LOD and LOQ values of 0,07 and 0,24 μg/mL, respectively. The precision and accuracy of the method were satisfying with intra and interday recovery values of 97,8-100,8% and RSD less than 2%. The proposed CE method was applied to asenapine tablets successfully, for the first time.