Abstract
Effects of drugs on the cardiovascular system are required to be assessed as part of safety pharmacology, in particular using the in vitro Human Ether-a-go-go Related Gene Product (HERG) and Purkinje fibre studies and can be used to predict safety margins prior to administration to man. Recent International Conferences on Harmonization (ICH) regulations, draft ICHS7B guidelines, indicate that levels of drug in bath solutions used should be measured if quantitative data are to be obtained for the estimation of safety margins. To accurately measure drug concentrations in bath solutions, a validated analytical method is required. This method is required to be accurate, precise, specific, and robust, and due to the increased potency of new drugs, liquid chromatography with mass spectrometric detection (LC–MS) has become the method of choice. Recent experiences validating methods for the analysis of a wide range of drugs in bath solutions has presented a major issue regarding the solubility of some drugs in bath solutions. This has resulted in the requirement of a different approach to the analysis of, in particular, lipophilic drugs that has in turn highlighted the potential for the significant overestimation of the drug concentration in these bath solutions and therefore inaccurate calculation of safety margins.
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