General guidance for method development in separation sciences

2 General guidance for method development in separation sciences 

Nowadays, in the pharmaceutical industry, the need to obtain accurate and rehable analytical data faster and more cost-effectively, has meant that approaches to method development are becoming simpler and more straightforward. These sinpler approaches have the benefits of more consistent methods, lower method diversity, reduced inventory costs for separations consumables and more easily transferable methods from R D laboratories to manufacturing quality control (QC) laboratories. Many pharmaceutical companies have adopted this approach. 

A review of method development in separation sciences indicates that individual approaches exist which are based on previous experience of compounds or previous knowledge method development often follows the same sequence of events. These are summarised in the flowchart shown in Fig. 2.1. In the following sections, each step is discussed in some detail. 

Before the method development commences, it is important to define as clearly and in as much details as possible what the objectives and goals are for the intended separation. There are many publications [1, 34-36] that detail the types of questions that should be asked and in many cases, these questions are specific for HPLC [35, 36]. However, by considering these questions in a broader sense, they can apply equally to most, if not all, common separation techniques. The following questions should be asked  

Defining the aims and objectives of the separation helps in deciding the choice of separation technique. Moreover, if the aim is to isolate purified material, then separation techniques such as GC and CE are not always easy to use. 

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