DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF ACALABRUTINIB

Abstract

The goal of this work was to create a new, fast, and accurate UV spectrophotometric method for quantifying acalabrutinib in pure and capsule dose forms. Water & ethanol were used in the ratio of 70:30 as a diluent. The highest absorbance of acalabrutinib was measured at 294 nm, and the linearity ranged from 2.5 to 15 g/ml. The regression equation for acalabrutinib was y= 0.0583x + 0.0053, with a correlation value of 0.9995. The percentage of recovery ranged from 99.87 to 100.71 percent. The relative standard deviation for intraday precision and interday precision was determined to be less than two. Acalabrutinib's LOD and LOQ were determined to be 0.006 g/ml and 0.197 g/ml, respectively. The spectrometric technique was validated in accordance with ICH criteria and was found to be suitable for routine quantitative measurement of acalabrutinib in pure and capsule dose forms. Keywords: Acalabrutinib, Method development, Ethanol