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

Abstract

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.