Analytical Method Development and Validation of RP-HPLC for Estimation of Asenapine Maleate in Bulk drug and Tablet Dosage Form

Author(s)

Patel P.S., Patel C.N., Patel M.M.

Author's Affiliation

Abstract

A new simple, specific, sensitive, rapid accurate and precise RP-HPLC method was developed for the estimation of Asenapine in bulk and pharmaceutical formulation (sublingual Tablet). Asenapine was chromatographed on Grace Altima C18 (100mm X 4.6 mm, 5μ) in a mobile phase consisting of mixture of Buffer (Potassium Di-hydrogen Phosphate buffer, pH 4.5) and Acetonitrile (65:35 % V/V).  The mobile phase was pumped at flow rate of 1.5 ml/min with detection at 220 nm. Linearity was performed with 7 levels, within the range of 50 % to 150 % of the sample concentration. The intra and inter day variation was found to be less than 2.0%. The mean recovery of the drug from the solution was 100.1%. Hence it can be applied for routine quality control analysis of Asenapine in bulk and pharmaceutical formulation.

Keywords

Asenapine, Asenapine Maleate, RP-HPLC, Assay, Estimation, Validation

Cite This Article

Patel P.S., Patel C.N., Patel M.M. (2016). Analytical Method Development and Validation of RP-HPLC for Estimation of Asenapine Maleate in Bulk drug and Tablet Dosage Form, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(4), 15-19.