The development of robust analytical methods is fundamental to the successful release of finished products.  In recent years, several approaches to reduce the time spent developing these analytical methods have been made by manufacturers of equipment, software, and column technologies.  Ultra High Pressure Liquid Chromatography (UHPLC) systems and method development software have shown to be useful tools for efficient and successful development.  Although these tools are useful, they require significant capital investment. An alternative approach to method development will be presented in which various column chemistries, pH ranges, and organic modifiers were screened to generate retention time data.  The retention times were then graphed to generate curves that were used to determine separation conditions for the active ingredients in 10 herbicide products.  The data was generated using conditions suited for traditional HPLC pressures by utilizing a rocket format HPLC column; the rocket format contains sub 2 micron particles packed into a large diameter HPLC column.  In this experiment, a Dionex method development system was used to screen 4 different Grace Vision HT� column chemistries, 2 organic modifiers, and 8 different pH buffers.

Systematic approach to method development in support of formulation development

246th National Meeting (2013)

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