Analytical Quality by Design-Based RP-HPLC Method for the Quantification and Stability Assessment of Nilotinib in Bulk and Nanoformulations

ABSTRACT

Background: Nilotinib, a tyrosine kinase inhibitor of the second generation, is susceptible to stress-induced degradation that could undermine therapeutic effectiveness. Materials and Methods: The accelerated stability studies have been performed on both bulk Nilotinib as well as its nanoformulation in an acidic, basic, oxidative, thermal, and photolytic environment following ICH-recommended guidelines. The developed RP-HPLC method showed efficient separation of Nilotinib from its degraded products and thus is proven to be an appropriate stability-indicating analytical method for the analysis of Nilotinib and its nanoformulation. Supporting Fourier-Transform Infrared Spectroscopy (FTIR) analysis offered molecular-level proof of these changes. Results: Degradation processes included amide hydrolysis, dealkylation, oxidative N-oxide formation, thermal rearrangement, and photolytic radical-mediated cleavage. In all conditions of stress, the nanoformulation uniformly showed diminished degradation than the bulk drug, which emphasizes the shielding effect of the carrier matrix. Conclusion: In combination, HPLC and FTIR profiling created a complete degradation map of Nilotinib, highlighting the nanoformulation's improved stability and corroborating its viability for enhanced therapeutic dependability.

KEYWORDS

• Analytical Quality by Design (AQbD)
• Box-Behnken Design
• Nilotinib
• Pharmaceutical Analysis
• RP-HPLC
• Stability-Indicating Method

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• DOI10.5530/ijper.20264633Copy

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