A novel capillary electrophoresis method for the quantification of asenapine in pharmaceuticals using Box-Behnken design
- PDF / 891,509 Bytes
- 9 Pages / 595.276 x 790.866 pts Page_size
- 32 Downloads / 168 Views
ORIGINAL PAPER
A novel capillary electrophoresis method for the quantification of asenapine in pharmaceuticals using Box‑Behnken design Sona Aliyeva1 · Sakine Atila Karaca1 · Alper Uğur2 · Arın Gül Dal Poçan1 · Duygu Yeniceli Uğur1 Received: 13 February 2020 / Accepted: 18 June 2020 © Institute of Chemistry, Slovak Academy of Sciences 2020
Abstract A new capillary electrophoresis (CE) method was presented for the determination of asenapine, an atypical antipsychotic drug, in pharmaceuticals. 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 ℃ 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. Graphical abstract
Keywords Asenapine · Capillary electrophoresis · Determination · Experimental design · Tablet analysis Electronic supplementary material The online version of this article (https://doi.org/10.1007/s11696-020-01256-5) contains supplementary material, which is available to authorized users. Extended author information available on the last page of the article
13
Vol.:(0123456789)
Chemical Papers
Introduction Schizophrenia is a well-known mental disorder which is characterized by auditory hallucinations, delusions, disorganized thoughts, lack of motivation, social withdrawal and also memory impairments (Volk and Lewis 2015). Asenapine (ASE) is an antipsychotic drug used in the treatment of schizophrenia. It is also effective in treating manic and mixed episodes of bipolar disorder. The molecule contains two chiral centers as seen in Fig. 1 and can exist as four stereoisomers. Two trans isomers have higher binding affinity to receptors than the cis isomers, therefore ASE has been approved in the form of a racemate of R,R- and S,Senantiomers (Protti et al. 2018). It has been commercially
Fig. 1 Chemical structure of ASE
available in sublingual tablet form since 2009 in the USA (Citrome 2014). ASE has affinity on serotonin receptors, dopamine receptors, adrenergic receptors, histamine (H1) receptors and also moderate affinity on histamine (H2) receptors. (Gonzalez et al. 2011). Several methods were reported for ASE determination in biological samples using liquid chromatography (Kovatsi et al. 2015; Protti et al. 2018), liquid chromatography-mass spectrometry (de Boer et al. 2012a,b ; Ansermot et al. 2013; Reddy et al. 2013; Patteet et al. 2014; Sempio et al. 2014; Sistik et al. 2016; Patel et al. 2018) and gas chromatographymass spectrometry (Miller et al. 2013). Also, there
Data Loading...
