"Analytical Quality by Design: A Review for Chromatography"

Abstract

Background: In recent times, product quality has been a primary focus in the pharmaceutical industry. The quality by design (QbD) strategy contributes to higher productivity through the application of several approaches, such as process analytical technology (PAT), analytical target profiling (ATP), critical quality attribute (CQA) assessment, and quality target product profiling (QTPP) (QTPP). Objectives: To summarize the quantitative applications of HPLC, HPTLC, UPLC and UHPLC by applying Analytical Quality by Design. Methods: This article shows current quantitative applications of Analytical QbD in analytical method development like HPTLC (High-Performance Thin Layer Chromatography), HPLC (High-Performance Liquid Chromatography), UPLC (Ultra-Performance Liquid Chromatography) and UHPLC (Ultra-High-Performance Liquid Chromatography) for more than 60 drugs. Result: To demonstrate drug quality, the ICH recommendations Q8, Q9, and Q10 for pharmaceutical development, quality risk management, and pharmaceutical quality management, respectively, have been produced. Conclusion: All found methods required very less time for detection and it improves the quality by applied all analytical methods.