Abstract
A simple, specific and stability-indicating reversed phase high performance liquid chromatographic method was developed for the quantitative determination of asenapine in tablet dosage form. A SunFire C18, 5 μm column having 250×4.6 mm i.d. in isocratic mode, with mobile phase containing 0.02 M potassium dihydrogen phosphate: acetonitrile (95:05, v/v, pH 3.5 adjusted with 1% o-phosphoric acid) was used. The flow rate was 1.0 mL min−1 and effluents were monitored at 232 nm. The retention time of asenapine was 5.51 min. The linearity for asenapine was in the range of 0.1–20 μg/ml. The recoveries obtained for asenapine were 98.31–101.51%. Asenapine stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation, sunlight and dry heat degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. Stressed samples were assayed using developed LC method. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of asenapine in tablet dosage form.
Highlights
Asenapine maleate (Org 5222, ASP) is a novel dibenzoxepinopyrrole [rel-(3aR,12bR)-5chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-but2-enedioate] (Figure 1) with unique receptor pharmacology and is available as a fastdissolving tablet for sublingual administration
In the European Union ASP is associated with the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults [3] (European Medicines Agency, 2010)
Forced degradation study Chromatogram of base hydrolysis performed at 80°C for 24 h reflux showed degradation of ASP with degradation product peak at retention time (RT) 6.086 min (Figure 3)
Summary
© Chhalotiya et al.; licensee Österreichische Apotheker-Verlagsgesellschaft m.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
