Welcome to the tenth edition of Chromatography Today an edition dedicated to chromatography method development. Method development or the ability to produce a robust and validated chromatographic method is one of the key goals to all practicing chromatographers and when done fully and well can be a great source of personal satisfaction. The process of achieving the perfect method can however, as many of you will know, be
frustrating, time consuming and in some cases feel like searching for the Holy Grail.
The key to successful method development is to initially set your specification and then plan for success by making sure you have all the necessary information, equipment and skills to enable you to have a good chance of success. There is now a wealth of knowledge and expansive method databases available from instrument companies and on the various scientific publications webs sites to give you a good starting point in terms of technologies, methodologies and experimental conditions used. However the real challenges comes when you have to start from scratch or when as in the case of a number of the articles in this addition it is a new technology or the sample matrix is complex. In today’s measurement driven world the problems of method development are not getting any easier. Samples are becoming more complex, regulatory requirements are driving down the limits of detection and having developed the method we now have show its robustness through validations and method transfer.
Whilst technology is offering more options to solve some of the problems, they all merely serve to increase the number of variables the chromatographer has to consider before starting the method development.
At one time we only had a few column chemistries and configurations to consider; now if we take HPLC as an example, we have an array of different bonding chemistries, particle sizes and porosity, not to mention column lengths and diameters. Similarly the advent of well engineered gradient systems in HPLC and pressure/flow programming in GC has given us more options in the control and selectivity of the separations.
The choice of detectors available to the chromatographer has also increase - we have progressed from the old dependable chromatography standbys of UV for HPLC and FID for GC to a generation of intelligent MS options which can provide reliable mass sensitive detection with the capability of both universal / selective monitoring and identification. These options have now spawned a sub branch of method development ”method optimisation” fuelled by the drive for faster analysis and in the pharmaceuticals area a whole new movement - “Quality by Design”. Help has been provided with the development of both hardware and software solutions. We have seen the development of turnkey fully automated method development systems in HPLC and automated sample preparation options for both HPLC and GC. Software solutions have also evolved with the development of chromatography modelling programs, such as DryLab®, ChromSword™, or Chrom Manager™, and there is much in the literature provide by both instrument companies and the reviewed papers on column selection.
This edition of Chromatography Today will hopefully give you flavour for the many issues and options associated with method development and give you an insight into the challenges of technology options such as UPLC, LC-MS and GC/MS/MS and the problems associated with complex samples such as proteins, blood, plasma and the difficult task of separating and identifying biomarkers.