QbD-Driven Optimization and Validation of an HPTLC Method for Quantitative Determination of Bosutinib

A Quality by Design (QbD) driven HPTLC method was developed and validated for quantitative determination of Bosutinib. Three Factor I – Optimal Design was employed to optimize mobile phase composition, saturation time and detection wavelength. The optimized chromatographic condition using acetonitrile 7: water 3: glacial acetic acid 0.5 with densitometric detection at 267 nm produced compact and well resolved bands with Rf value around 0.6. The method demonstrated excellent linearity over 200–1200 ng/spot (R² = 0.9956) with regression equation y = 3.3397x + 45.207.
Precision studies showed repeatability of 0.29% RSD with intra- and inter-day precision below 2%. Accuracy 99.08 %. LOD and LOQ were 12.17 and 36.88 ng/spot respectively. Robustness evaluation confirmed minimal influence of deliberate variations and assay results showed 101.80 ± 1.08 %. Greenness assessment revealed AGREE score of 0.57 indicating environmentally acceptable analytical performance.