A new stability indicating RP-HPLC method for the estimation of Acalabrutinib

Acalabrutinib is an anti-cancer drug used for metastatic prostate cancer treatment. A new stability indicating RP-HPLC method was developed and validated for the determination of Acalabrutinib in tablets. Shimadzu HPLC Model no. iSeries 2050C 3D with Lab solutions Software with PDA detector and Shim-pack GIST C18 column (250 × 4.6 mm, 5µ) were used for the present study. A mixture of 0.02M of Ammonium acetate (pH adjusted to 4.0 with glacial acetic acid) and Acetonitrile (50: 50, v/v) was used as mobile phase with flow rate 1.0 mL/min were the optimised chromatographic conditions (Detection wavelength 285 nm). The method was linear over the concentration range 0.2-150 µg/ml with linear regression equation, y = 18135x + 1732.4 (R² = 0.9998). The LOQ and LOD were found to be 0.1932 µg/ml and 0.06354 respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines.