VALIDATED RP-HPLC ASSAY METHOD FOR DETERMINATION OF ACALABRUTINIB IN PHARMACEUTICAL FORMULATION BY QBD APPROACH

A method by using a quality-by-design approach for the development and validation of an RP-HPLC method for determination of Acalabrutinib in API and marketed formulation. Chromatogram was run through SunFire C18 Column, 100Å, 10 µm, 4.6 mm X 150 mm. Mobile phase containing 0.1% OPA: Ethanol and water (50:50) taken in the ratio 60: 40 (%v/v) was pumped through the column at a flow rate of 1.0 ml/min. Temperature was maintained at 30°C. The optimized wavelength selected was 220nm. The retention time of Acalabrutinib was found to be 2.343 min %RSD of the Acalabrutinib was found to be 1.0%. %RSD of Method precision of Acalabrutinib was found to be 0.3%. %Recovery was obtained as 100.47% for Acalabrutinib. LOD, LOQ values obtained from the regression equation of Acalabrutinib were 0.28, 0.86. The regression equation of Acalabrutinib is y = 17109x + 5534.8. The method was easy to use and cost-effective, making it suitable for frequent quality control testing in industries. Both retention times and run times were reduced. Results which were obtained from the validation of the developed analytical method were within the limit as per ICH guidelines.