Quality by design-based RP-HPLC methods for pharmaceutical analytical estimation: A review

Area of Science:

• Pharmaceutical Analysis
• Analytical Chemistry
• Quality by Design

Background:

• Traditional method development often lacks robustness and reproducibility.
• Analytical Quality by Design (AQbD) offers a systematic, risk-based framework for method development.
• AQbD integrates quality considerations from the initial stages of method design.

Purpose of the Study:

• To explore the integration of AQbD principles into Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) method development.
• To highlight how AQbD addresses limitations of traditional methods in pharmaceutical estimation.
• To demonstrate the benefits of AQbD for method robustness and validation.

Main Methods:

• Defining an Analytical Target Profile (ATP).
• Conducting comprehensive risk assessments (e.g., Ishikawa diagrams, FMEA).
• Utilizing Design of Experiments (DoE) for screening and optimization.

Main Results:

• AQbD leads to a thorough understanding of Critical Quality Attributes (CQAs) and Critical Method Parameters (CMPs).
• Establishment of a Method Operable Design Region (MODR) enhances method robustness and reliability.
• AQbD application supports key analytical method validation parameters like accuracy, precision, and linearity.

Conclusions:

• AQbD significantly enhances the robustness and reliability of RP-HPLC methods for pharmaceutical analysis.
• The systematic approach of AQbD aligns with regulatory guidelines such as ICH Q2.
• Future pharmaceutical analysis will increasingly rely on AQbD and technological advancements for product safety and efficacy.