Method Development and Validation of RP-HPLC Method for Determination of New Antipsychotic Agent Asenapine Maleate in Bulk and Pharmaceutical Formulation

摘要

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-1with coefficient of correlation 0.999. The proposed method was validated with respect to linearity, accuracy, precision and robustness.