Implementation of Quality by Design Approach for Developing Chromatographic Methods with Enhanced Performance: A Mini Review

Abstract

Quality by Design (QbD) is a newer paradigm being widely implemented by pharmaceutical industries for producing robust drug products with consistency in their quality as per the predefined objectives. The QbD approach emphasizes on building quality from the beginning and helps developing products that meets the consumer and regulatory requirements. QbD in pharmaceutical formulation and development is already trending with astounding success. However, the application of QbD in analytical sciences, also refereed as Analytical QbD (AQbD) is yet to receive the acceptance and recognition from the scientific community. AQbD implementation endeavors to facilitate development of quality analytical methods with improved method performance meeting the regulatory flexibility to work within a robust design space in order to avoid failures during method transfer process. It can be effectively applied to diverse areas including analysis of APIs and related substances, forced degradation products, optimization of sample preparation techniques for drug products for their quantification in biological samples. The present mini-review, in this regard, provides an overview of the vital precepts of AQbD, salient features, different stages involved during development of AQbD compliant analytical methods, and highlights of the recent literature instances related to the AQbD applications in pharmaceutical analysis.