Research Article
Braj Kishor Yadav, N. K Sathis
Abstract
A new, simple, accurate, precise, sensitive, specific and economical Reverse Phase Ultra-Fast Liquid Chromatography (RP-UFLC) method was developed and validated for the determination of Asenapine Maleate in bulk and pharmaceutical dosage forms. An Eclipse plus C-8, 5 μm particle size column having 4.6 x 250 mm internal diameterin gradient mode, with mobile phase containing Acetonitrile: Methanol (25:75 v/ v) was used. The flow rate was 1 ml / min and effluents were monitored at 210 nm. The sample was injected into the RP-UFLC by manual injector, separation was achieved within 10 min.The retention time for Asenapine Maleate standard drug was 1.9 minute and for sample was 1.9 minute with some additional peaks. The method was validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantification, and robustness. The limit of detection (LOD) and limit of quantification (LOQ) for estimation of Asenapine maleate was found to be 1.14 μg / mL and 3.46 μg / mL, respectively. Recovery studies of Asenapine maleate was found to be in the range of 98.38–101.43 %. The linearity for Asenapine Maleate was in the range of 0-25μg/ml. The correlation coefficient was found to greater than 0.998. Thus, proposed method can be successfully applied for the quantitative determination of Asenapine maleate in bulk and pharmaceutical dosage forms.