Automation and validation of HPLC-systems

Summary The automation of chromatographic systems is of increasing interest to industry and research laboratories in routine applications. Besides potentially saving time or making better use of available instrumentation, automation also improves the quality of results by producing more precise and more reproducible HPLC data. The need for the validation of methods and qualification of instruments is increasingly recognised in order to ensure compliance with legal requirements (e.g. in the pharmaceutical industry) and to ensure the reliability of analytical results. Possibilities and requirements for automated HPLC systems are elaborated. Emphasis is placed on defining the goals of validation and on discussing different aspects of the validation of LC methods, system suitability tests, ruggedness of methods and the transfer of LC methods from laboratory to laboratory. Adequate strategies of HPLC method development provide very useful information on the validation and ruggedness of LC methods.