ABSTRACT
Method development and optimization is the foundation of any validated method; a properly developed and optimized method can help to ensure a method’s success upon implementation. Though the focus of this chapter is on HPLC methods, by and large, the conceptual steps outlined here for method development and optimization will also be applicable to many analytical procedures performed in a regulated environment, including, but not limited to, gas chromatography (GC), capillary electrophoresis (CE), or mass spectrometry (MS). In this chapter, different approaches to method development and optimization in a regulatory environment are discussed, along with suggested HPLC instrument configurations and software tools.
