Development and validation of HPLC methods for analysis of pharmaceutical formulations

7. Summary Development and validation of HPLC methods The doctoral thesis concerns with development of HPLC methods for analysis of pharmaceutical formulations, which meet all requirements for suitability, precision and reliability. Documentation of these parameters is called validation. At first theoretical principles of chromatography are described in this work, with the emphasis to liquid chromatography, included HPLC. The instrumentation in HPLC is described, mentioning the new trends in stationary phase's development - for example monolithic columns, zirkonia stationary phase, HILIC and sub-2-microns phases. In the other part UPLC system, one of the new trends in liquid chromatography development is discussed. Next part deals with the development of HPLC methods for analysis of pharmaceutics and is followed by chapter, in which analysis of pharmaceutical formulations is described, included preparation of the samples before analysis, stability monitoring and further the analysis of impurities. The last, relatively large chapter is dealing with the validation of analytical methods. Several institutions are concerned with validation requirements. They issue recommendation and/or guidelines, which are cogent for this process. In the Czech Republic there exists State Institute for Drug Control (SUKL -..