Title of the article: development and validation of UV-VIs spectroscopic method for quantification of ibrutinib, an anticancer drug

Ibrutinib, an International Nonproprietary Name (INN) drug that inhibits Bruton’s tyrosine kinase (BTK), is a key treatment for various hematological malignancies, requiring reliable analytical methods for quality control and quantification in pharmaceutical formulations. This study aimed to develop and validate a UV-Vis spectroscopic method for quantifying Ibrutinib, following ICH guidelines. Ibrutinib was analyzed in raw materials and pharmaceutical dosage forms using solutions at various concentrations to construct a calibration curve. The method's accuracy, precision, ruggedness, robustness, limit of detection (LOD), and limit of quantification (LOQ) were evaluated. Maximum absorbance occurred at 213 nm and 288 nm, with a regression equation of y=0.059x−0.007. The determination coefficient (R²) was 0.999, indicating excellent linearity. The dynamic range was 1.56–25 μg/mL, and the % Relative Standard Deviation (RSD) for precision, robustness, and ruggedness was below 2%. The LOD was 0.419 μg/mL and the LOQ 1.27 μg/mL, demonstrating a robust, accurate, and simple method for routine quality control of Ibrutinib.