Chapter 6 - Analytical quality by design for high-performance thin-layer chromatography method development

Abstract

Quality by design (QbD) is a logical and scientific strategy employed for the development of a pharmaceutical product. It is initiated with predefined objectives and deals with the management of risk factors to achieve control of a pharmaceutical process. It is possible to extend and apply QbD to analytical sciences like high-performance thin-layer chromatography (HPTLC) for attaining maximal method performance. Hence change from quality by testing to QbD in analytical sciences has been prominently increasing in research settings and industry. HPTLC, an advanced type of thin-layer chromatography, is a sophisticated technology for quantitative and qualitative analyses. This chapter provides an outline of the benefits of applying QbD to HPTLC, including its method development and validation. HPTLC in association with the principles of analytical QbD would improve robustness, decrease wastage of resources, time, and essentially, the failure of the validation step. This would go a long way in achieving a better understanding of HPTLC variables affecting its performance via tools of assessing risk and designing experiments.