An Ultra Performance Liquid Chromatography-PDA Method for the Determination of a Novel Antipsychotic-Blonanserin in Bulk and its Tablet Dosage Form

Abstract

To develop a new ultra-high-resolution liquid chromatographic technique for determining Blonanserin concentrations in APIs and tablets. A DIKMA Endoversil (2.1 x 50mm, 1.7µm) column with a flow rate of 0.4 mL/min and an eluent measured at 237 nm was used for the chromate-graphic separation. Phosphate buffer, pH 4.2, and acetonitrile (25:75) were used as the mobile phase, with a flow rate of 0.4 mL/min. The method was approved in accordance with the principles established by the International Conference on Harmonization. Blonanserin was eluted in this process with a retention time of 0.607 minutes. Blonanserin calibration curve plots were shown to be linear for the concentration ranges of 1-75 µg/mL. The quantification limit was 0.25 µg/mL, while the detection limit was 0.05 µg/mL. Despite the fact that the current method was found to be effective in the analysis of Blonanserin in a force degrading state, the percent assay of the marketed dosage form was found to be 96.80%. All of the study results' experience pieces of evidence demonstrated the usefulness of Blonanserin estimation in API and tablet formulation.