Development and validation of stability-indicating UHPLC methods for bortezomib injection solutions

A rapid and robust stability-indicating Ultra-High-Performance Liquid Chromatography (UHPLC) method was developed and validated for the quantitative determination of bortezomib in injectable formulations. The method employed a C18 column with gradient elution using a phosphate buffer and acetonitrile, achieving optimal separation within a short runtime. Linearity was confirmed across the concentration range of 2–10 mg/mL with R² > 0.999. The method was validated in accordance with ICH Q2(R2) guidelines, demonstrating specificity, precision, accuracy, robustness, and solution stability. Forced degradation studies under acidic, basic, oxidative, thermal, and photolytic stress confirmed that the method is capable of separating bortezomib from its degradation products with acceptable mass balance. The developed method is suitable for routine quality control and stability analysis of bortezomib injection solutions.