Quality by Design (QbD) has become a new concept for development of quality pharmaceutical products, It is an essential part of the modern approach to pharmaceutical quality, QbD is a best solution to build a quality in all pharmaceutical products but it is also a major challenge to the Pharmaceutical industry whose processes are fixed in time, despite inherent process and material variability, Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA). On the basis of this we can design the product formulation and process to meet the product attributes. This leads to recognise the impact of raw materials [critical material attributes (CMA)], critical process parameters (CPP) on the CQAs and identification and control sources of variability. QbD is an emerging idea which offers pharmaceutical manufacturer with increased self-regulated flexibility while maintaining tight quality standards and real time release of the drug product, This paper discusses the pharmaceutical QbD and describes how it can be used to develop the pharmaceutical products well within the specified period of time.

Dienogest is used for of treatment of endometriosis. A Stability indicating Reversed phase high Performance Liquid Chromatographic method has been developed for the determination of Dienogest in bulk as well as in innovator Product (Visanne Tablets 2mg). Various Critical issues regarding chromatographic conditions are resolved using Thermo Hypersil BDS C18 150 x 4.6mm, 5µm or equivalent column. 40% Acetonitrile is used as Mobile Phase for elution of very distinct Peak for the Dienogest. The developed Method has been validated as Per ICH Q2B to asses the method as simple, Precise, accurate and robust enough to withstand the changes in Method Parameters. The Peak of Dienogest is eluted near the Retention time of 4.5 Minutes