ANALYTICAL QUALITY BY DESIGN AND GREEN ANALYTICAL CHEMISTRY: EMERGING STRATEGIES FOR MODERN PHARMACEUTICAL ANALYSIS

Author

Kummari Shirisha


Abstract

 Pharmaceutical analysis plays a fundamental role in establishing the identity, purity, strength, safety, efficacy and quality of pharmaceutical substances and products. Conventional analytical method development has traditionally depended on trial-and-error experimentation, followed by validation after the method has been optimized. The introduction of Analytical Quality by Design (AQbD) has transformed this approach by incorporating scientific understanding, risk assessment and systematic experimentation during analytical procedure development. The recently implemented ICH Q14 guideline provides a science- and risk-based framework for analytical procedure development, while ICH Q2(R2) provides current principles for analytical procedure validation. At the same time, increasing concern regarding solvent toxicity, chemical waste, energy consumption and environmental impact has accelerated the development of Green Analytical Chemistry (GAC). Modern pharmaceutical analysis is therefore moving towards analytical procedures that are not only accurate, precise and robust, but also sustainable, rapid and environmentally responsible. Advanced techniques such as UHPLC, LC-MS/MS, high-resolution mass spectrometry, Raman spectroscopy, near-infrared spectroscopy, chemometrics, miniaturized sample preparation and automated analytical systems are increasingly contributing to this transformation. This review discusses the principles of AQbD, analytical target profile, critical method attributes, risk assessment, design of experiments, method operable design region, analytical procedure validation, green analytical chemistry, green chromatographic techniques and emerging analytical technologies. The integration of AQbD with green analytical principles can provide robust, reliable, efficient and sustainable analytical procedures throughout the pharmaceutical product lifecycle.


Keywords

Pharmaceutical analysis, Analytical Quality by Design, AQbD, ICH Q14, ICH Q2(R2), Green Analytical Chemistry, UHPLC, LC-MS, Chemometrics, Analytical lifecycle management.



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References


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