Rapid Method Development

A stepwise procedure for rapid HPLC-MS/MS method development that was described recently by Xu et al. [10] is shown in Fig. 13.5. As shown in Fig. 13.5, there are three proposed checkpoints that are used to test the assay before it is used for the actual PK samples. If the assay (HPLC-MS/MS procedure) passes a

Steps Hplc Method Development
Fig. 13.5 A schematic diagram showing the stepwise procedure for rapid method development of HPLC-MS/MS methods for discovery PK assays. Adapted from [10], with permission from the American Chemical Society.

checkpoint, then it moves to the next checkpoint; if it fails, then there are potential remedies to address the problem as shown in the schematic. The concept behind this schematic is that most discovery PK assays will pass all of the three checkpoints and can then be used for the sample analysis. When the method is used for sample analysis, then there needs to be additional rules to determine whether or not the assay is suitable, so that the results can be reported. While discovery PK assays are not bound by the rules of good laboratory practice (GLP), Korfmacher [6] has proposed a set of rules (vide infra) that can be used for various types of discovery PK assays.

410 | 13 Mass Spectrometry in Early Pharmacokinetic Investigations 13.6

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