METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF UMBRALISIB USING RP-HPLC

Abstract

RP-HPLC methodology for quantifying Umbralisib in pharmaceutical formulations. The chromatogram was analysed using an Inertsil C18 column of 150 x 4.6 mm with a particle size of 5 μm. The mobile phase, including 0.1% TFA and acetonitrile in a 70:30 ratio, was injected through the column at a flow rate of 0.9 ml/min. The buffer utilised in this procedure was a 0.1% TFA (pH 4.8) solution. The temperature was sustained at 26°C. The selected optimised wavelength was 210.0 nm. The retention time of Umbralisib was determined to be 2.683 minutes. The %RSD of Umbralisib was determined to be 0.8, whereas the %RSD of the method precision for Umbralisib was discovered to be 0.4.The recovery for Umbralisib was determined to be 99.73%. The limits of detection (LOD) and quantification (LOQ) values derived from the regression equation of Umbralisib were 0.03 and 0.08, respectively. The regression equation for Umbralisib is y = 44120x + 4646.3. The retention periods and run times were reduced, indicating that the suggested approach is straightforward and cost-effective, suitable for frequent quality control testing in industries.