Reversed-phase method development can be a very time-consuming and demanding task, particularly if your samples contain many analytes, and if you don’t follow a systematic approach. In industrial and pharmaceutical research laboratories, researchers often must develop analytical methods that require the separation of tens of components including active pharmaceutical ingredients (APIs), process impurities, API degradants, formulation excipients, as well as degradants resulting from chemical reactions between APIs and excipients.

The development of a robust and rugged separation and method that can be validated and used in multiple laboratories over period of 10-20 years can be a significant challenge. Some pharmaceutical companies dedicate a group of individuals whose main responsibility is to develop, continuously improve and apply a designated set of stationary phases and analysis conditions, which they use to carry out column and condition screening for new drug entities. The results of their screening efforts can then be transferred to other investigators, who then carry out further method development, refinement and validation using the learnings gained from the screening group’s experiments. Conversely, there are other situations where a method development project only entails the separation of a limited number of analytes, and the resulting method will only be used in the method developer’s laboratory for a few weeks or months. In such situations, an acceptable separation of only 5-10 compounds is necessary.

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