Performance evaluation of a MIP for the MISPE-LC determination of p-[F]MPPF and a potential metabolite in human plasma.

Within the family of serotonin (5-HT) receptors, the 5-HT subtype is particularly interesting as it may be involved in various physiological processes or psychological disorders. The p-[F]MPPF, a highly selective 5-HT antagonist, is used for in vivo studies in human or animal by means of positron emission tomography (PET) [1]. In order to selectively extract p-[F]MPPF and its main metabolites from plasma, molecularly imprinted polymer (MIP) was prepared against these compounds by using the p-MPPF as template.

Compromise in uncertainty estimation by modelling and validation approaches for an HPLC-UV method for measurement of biochemical indicators of vitamins A and E.

It is common practice nowadays to associate the measurement uncertainty to the measurand, in order to judge the quality of a result related to the measurement process. However, the improvement of this parameter as well as the adaptation of its estimation modes always remain an analytical challenge, especially in chemical testing. In this paper, we outline a measurement uncertainty estimation mode based on the one-point linear calibration equation to fully establish a "bottom-up" approach for estimating the measurement uncertainty of a multi-point calibration-based HPLC-UV quantitative method.

Fingerprinting and validation of a LC-DAD method for the analysis of biflavanones in Garcinia kola-based antimalarial improved traditional medicines.

African populations use traditional medicines in their initial attempt to treat a range of diseases. Nevertheless, accurate knowledge of the composition of these drugs remains a challenge in terms of ensuring the health of population and in order to advance towards improved traditional medicines (ITMs). In this paper chromatographic methods were developed for qualitative and quantitative analyses of a per os antimalarial ITM containing Garcinia kola.

Understanding the impact of microcrystalline cellulose physicochemical properties on tabletability.

The quality by design (QbD) initiative is promoting a better understanding of excipient performance and the identification of critical material attributes (CMAs). Despite microcrystalline cellulose (MCC) being one of the most popular direct compression binders, only a few studies attempted identifying its CMAs. These studies were based either on a limited number of samples or on MCC produced on a small scale and/or in conditions that deviate from those normally encountered in production.

Towards a full integration of optimization and validation phases: An analytical-quality-by-design approach.

When using an analytical method, defining an analytical target profile (ATP) focused on quantitative performance represents a key input, and this will drive the method development process. In this context, two case studies were selected in order to demonstrate the potential of a quality-by-design (QbD) strategy when applied to two specific phases of the method lifecycle: the pre-validation study and the validation step. The first case study focused on the improvement of a liquid chromatography (LC) coupled to mass spectrometry (MS) stability-indicating method by the means of the QbD concept.