QbD HPLC Method Development

I need a complete, Quality-by-Design driven analytical method for an active pharmaceutical ingredient built around RP-HPLC with UV detection. My goal is to move beyond a traditional one-factor approach and establish a science- and risk-based method that is rugged, reproducible, and fully ready for validation.

Please map out the entire QbD workflow—initial knowledge space, risk assessment, screening and optimisation DoE, establishment of the Method Operable Design Region, and the final control strategy. I will supply the compound, preliminary chromatographic conditions, and any relevant stability data once we start.

To be considered, include a detailed project proposal that walks me through your planned experimental design, software you intend to use (e.g., Design-Expert, Minitab, JMP), timeline, and how you will document each stage in line with ICH Q8-Q10 expectations. I am particularly interested in how you will demonstrate robustness, precision, accuracy, and solution stability, and how lifecycle management will be supported.

Deliverables (attach as separate files):
• Full DoE reports with raw data, statistical analysis, and response surface plots
• Finalised method parameters with justification of the MODR
• Draft validation protocol based on the developed method
• Concise summary slide deck for internal review

I will review proposals on clarity, scientific soundness, and past success with QbD-based HPLC method development.