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  • Article title
  • Abstract
  • Keywords
  • Introduction
    • Method development incorporating QbD
  • Materials and methods
    • Chemicals
    • Instrumentation and chromatographic conditions
    • Preparing standard solution
    • Sample preparation
    • Selection of wavelength
    • Method development with QbD assistance
      • Analytical target profile
      • Risk assessment – Evaluation of potential dangers
      • Conducting experimental design
      • Analysing the results of the experiments and optimizing the method
    • Validating the analytical method
      • Linearity
      • Accuracy
      • Precision
      • Specificity
      • Limits of quantification
      • System suitability
      • Robustness of the method
      • Forced degradation studies
  • Results and discussion
    • Selecting solvents and detection wavelength
    • Identifying analytical target profile and risk assessment
    • Method development and optimization of the proposed method
    • Defining design space
    • Validation of the analytical method
    • Application of the proposed approach to the prepared formulation
    • Results for stability studies
  • Conclusion
  • Author contributions
  • Acknowledgements
  • References
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