Optimization of Chromatographic Conditions with QbD for Method Development and Validation of Bosutinib by HPLC: Applications in Dosage Forms and Rat Plasma Analysis

Aim: Bosutinib (BST) is an anti-cancer medicine that used to treat a variety of different types cancer. Using the HPLC method analysis and Quality by Design (QbD) strategy, study aimed precisely quantify drug in tablet form rat plasma. Methodology: For developed method’s validation, chromatographic settings were fine-tuned making use Box–Behnken (BBD). In BBD, two dependent variables three independent selected. Isocratically, samples eluted, having eluent phase composition ammonium acetate (CH3COONH4) buffer pH 3.0 acetonitrile (CH3CN) (60:40% v/v), Raptor C-18 column at temperature 25 ∘C with flow rate 1 mL/min for 5 min. The wavelength detection was set 260 nm. this study, encorafenib (ENC) employed as internal standard. Result: A sharp resolved peak BST ENC retention time 1.92 min 4.01 min, respectively, observed method. limits quantification newly established found be 1.503 μg/mL−1 0.496 μg/mL−1. calibration curve’s linearity range between 2 20 μg/mL−1, r2 0.999. optimized verified compliance ICH guidelines. results all validation parameters within acceptable range, example, % RSD system suitability (0.63–4.46), linear regression (1.659), interday intraday precision value (1.723–1.892), (1.762–1.923), accuracy (1.476–1.982). Conclusion: quantity dosage plasma determined using simple, quick, robust devised validated.