Evaluating analytical results reliability using a Bayesian probability criterion

Methods validation is mandatory in order to assess the fitness of purpose of developed analytical method such as HPLC, GC, etc. Of core importance at the end of the validation is the evaluation of the reliability of the individual results that will be generated during the routine application of the method. Regulatory guidelines provide a general framework to assess the validity of a method, but none address the issue of results reliability. In this study, a proposed Bayesian approach provides the effective probability of obtaining reliable future analytical results over the whole concentration range investigated. This is summarized in a single graph: the reliability profile. This Bayesian reliability profile is also compared to a frequentist approach derived from the work of Dewe et al. [1]. Furthermore, to illustrate the applicability of the Bayesian reliability profile, this approach is applied to a bioanalytical method dedicated to the determination of ketoglutaric acid (KG) and hydroxymethylfurfural (HMF) in human plasma by SPE-HPLC-UV..