Stability-Indicating Liquid Chromatographic Method for the Quantification of the New Antipsychotic Agent Asenapine in Bulk and in Pharmaceutical Formulation

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.

Studies on photodegradation process of psychotropic drugs: a review

“…Paliperidone did not undergo photolysis under UV radiation (Sherje and Londhe 2015 ). Quetiapine is also photostable under ICH conditions, as well as UV-C radiation (Narendra et al 2011 ; Kumar et al 2013 ), asenapine under UV and sunlight (Chhalotiya et al 2012 ; Patel et al 2015 ), levosulpiride under UV radiation (Pal et al 2016 ), and aripiprazole under ICH conditions and UV-C irradiation (Srinivas et al 2008 ; Narayana and Chandrasekhar 2012 ; Pai and Dubhashi 2013 ). Exposure of amisulpride to sunlight for 48 h resulted in 9.5 % degradation (Dabhi et al 2013 ).…”

Stability-Indicating HPTLC Method for Quantitative Estimation of Asenapine Maleate in Pharmaceutical Formulations, Equilibrium Solubility, andex vivoDiffusion Studies

“…Most of the methods reported in the literature determined ASPM without taking into consideration the importance of its potential degradation products (Except LC method reported by Chhalotiya et al) [3] . Hence, the presented work aims to develop and validate a highly selective and specific analytical method for ASPM in presence of their potential degradation product/impurities.…”

“…The developed and validated HPTLC method of ASPM was correlated with reported stability indicating HPLC assay procedure [3] .…”

“…Results obtained by the suggested HPTLC method for determination of ASPM in its pharmaceutical formulation were statistically compared to those obtained by applying the reported HPLC method [3] . The calculated t-value was found to be 0.4686 (P = 0.6637) at 95 % confidence level (P = 0.05).…”

“…The linear correlation between measured signal and concentrations of ASPM was checked from 0.3-1.8 µg/band, for developed HPTLC method and 0.1-20 µg/mL was reported for HPLC method [3] . In HPTLC, the limit of detection was better than HPLC, while limit of quantitation was slight higher than reported for HPLC, both of which are insignificant (Table 8).…”