Publication

Abstract : A simple and accurate RP-HPLC method was developed for the estimation of Asenapine maleate in bulk and tablet dosage form. Isocratic elution at a flow rate of 1ml/min was employed on a C18 column. The mobile phase consists of methanol, n-butanol and glacial acetic acid in the ratio 60:20:20 v/v. The UV detection wavelength was 270 nm. The retention time for asenapine maleate was 1.9 min with an asymmetry of 0.95. The method was validated for several parameters such as accuracy, precision, robustness as per ICH guidelines. Linearity was observed in the range of 10-100 µg/ml with correlation coefficient of 0.998. The mean recovery were found to be in the range of 98.9-100.2% and the % RSD for interday and intraday was found to be 0.98 and 0.53 respectively. To investigate on the stability of drug, forced degradation studies were performed under different stress conditions recommended by International Conference on Harmonization (ICH). Stress degradation methods are used to understand the degradation chemistry of drug. The results of the study show that the proposed RP-HPLC method was simple, rapid, precise, accurate and stability indicating and hence can be sucessfully used for the routine analysis of Asenapine maleate in bulk and pharmaceutical formulation.