Abstract

VALIDATED STABILITY INDICATING ANALYTICAL METHOD FOR THE ESTIMATION OF ASENAPINE MALEATE USING UPLC METHOD

N. J. R. Hepsebah* and A. Ashok Kumar

ABSTRACT

Forced degradation studies were performed on asenapine maleate in asenapine sublingual Tablets (saphris-5mg), a reversed phase, stability indicating UPLC method was developed. Acetonitrile and ammonium acetate buffer (pH 5) at flow rate of 1 ml/min were used in isocratic elution mode. Separation was achieved by using chromosil C18 column (4.6 x 150mm, 5m) at 35ºC. UV detection was performed at 245 nm. Retention time is 2.160 min for Asenapine. Linearity was obtained in the range of 50μg/ml to 150μg/ml for Asenapine. The correlation coefficient was found to be 1 for the drug. The Recovery studies were performed in the range of 50% - 150 %. The % Assay is 100.2%. Forced Degradation studies were conducted according to the ICH guidelines and the Drug Product was found to be stable in all conditions. Hence, the method could be successfully applied for routine analysis.

Keywords: Asenapine, UPLC, ICH.