The objective of this work is to clarify and demonstrate the fundamental characteristics of Quality by design concept and describe how concept can be applied to the development of analytical methods with emphasis on its application in development, optimization and validation of HPLC methods and show how the principles of the life cycle can be used for analytical methods. The work also represents a database of HPLC methods that were developed and optimised with some elements of QbD concept. Research of this work is theoretical and includes a detailed review of available literature about QbD concept, applying of QbD concept in the development of analytical methods and specific application of QbD concept in the development and optimization of HPLC methods. The following bibliographic databases and services were searched: Medline/PubMed, Scopus, ScienceDirect and Research Gate and databases available on the website of the FDA, EMA and ICH. Overview of general guidelines for the implementation of QbD concepts in pharmaceutical development and explanation how they can be applied in the development, optimization and validation of analytical methods with emphasis on the application for HPLC methods will serve as a practical form for planning of development and validation program for analytical methods. Database of HPLC methods that were developed and optimized with elements of QbD concept can serve as a model for the development and optimization of HPLC methods. Application of QbD concept in the development of analytical methods ensures development of reliable, robust and rugged methods that enable reliable testing and confirmation of the quality of drug products throughout their entire life cycle. Using of QbD approach in development of analytical methods enables the regulatory flexibility since the basis for regulatory application is design space with acceptable range of relevant parameters. Using of softwares for development of HPLC methods allows fast and efficient QbD development of HPLC methods.