Analytical QbD Approach for Enhanced Robustness of HPLC Methods.

      Аннотация: Quality by Design (QbD) is a holistic approach used by pharmaceutical industries for obtaining enhanced and consistent quality products to meet the consumer requirements. It emphasizes on building quality from the beginning. The QbD has already gained popularity and success in pharmaceutical formulation development. But it can be a major role player in development of quality analytical methods assuring enhanced method performance. The current book manuscript provides an overview of the different stages involved in an Analytical QbD (AQbD) approach with intention of attaining enhanced method performance. Besides the book highlights a research case study depicting the effective implementation of AQbD approach towards development of a stability-indicating ultrafast liquid chromatography (UFLC) method with superior method robustness for quantification of a drug in API and pharmaceutical dosage form.

Ключевые слова: analysis, HPLC, Quality by design