UPLC METHOD DETERMINATION AND QUANTIFICATION OF BELUMOSUDIL AND ITS IMPURITIES IN THE HUMAN PLASMA SAMPLES

Abstract

This current analysis demonstrates the development of the related substances (RS) method for separating and quantifying BSL and its related substances from plasma using the UPLC technique. The solid phase extraction (SPE) method was employed to extract the belumosudil (BSL) and related impurities from plasma. This SPE method has been shown to have high recovery values for BSL and its related impurities. The method employed a column from Waters, specifically the X-Bridge BEH C18 150x4.6mm, 3.5µm, with a mobile phase flow rate (0.8 mL/min) and a UV-wavelength (250 nm). In this method, BSL and its impurities show good peak shapes and high resolutions. This developed method shows high sensitivity, accuracy, and precision values. While performing the stability studies, the drug was stable and it showed less than 4.53% degradation. Six different concentration solutions (BSL (25-250µg/mL) and impurities (3-18µg/mL)) were prepared for constructing linearity plots. The obtained linearity plot shows the accepted correlation coefficient (R2) value (≥0.999). The Limit of detection (LOD) and Limit of quantification (LOQ) were determined using the signal-to-noise (S/N) ratio method. This UPLC method was validated according to ICH guidelines.