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Method development and validation of RP-HPLC method for determination of new antipsychotic agent asenapine maleate in bulk and in pharmaceutical formulation | Abstract
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Abstract

Method development and validation of RP-HPLC method for determination of new antipsychotic agent asenapine maleate in bulk and in pharmaceutical formulation

Author(s): Nagarajan Govindarajan, Shirisha Koulagari, Archana Methuku, Sravanthi Podhuturi, Ramana Bachu Venkata

A novel isocratic reverse phase liquid chromatography method for determination of Asenapine Maleate was developed and validated after optimization of various chromatographic conditions. A Hiber C18, 5 μm column having 250×4.6 mm i.d., with mobile phase containing 0.05 M potassium dihydrogen phosphate : acetonitrile [60:40, v/v, pH 2.7 adjusted with 1% o-phosphoric acid] was used. The flow rate was 1.0 mL min-1 and effluents were monitored at 270 nm. The retention time of asenapine was 4.2min. The linearity for Asenapine maleate was in the range of 0-150 μg mL-1 with coefficient of correlation 0.999. The proposed method was validated with respect to linearity, accuracy, precision and robustness.