A Comparative Study of Human Dried Blood Spot and Conventional Plasma-Based Bioanalytical Methods Using Lc-Ms/Ms.

Abstract

Introduction: The conventional blood collection and analysis process has been made quicker by the use of DBS technology in the fields of therapeutics and health sciences. For pharmacokinetic and toxicokinetic investigations, DBS is expected to be a viable substitute for well-established liquid bio methods and potentially even outperform them provided if it comparable to conventional human plasma bioanalytical method.

Objectives: The purpose of this comparison study was to compare validated dried blood spot (DBS) method with traditional gold standard human plasma method for determining Remdesivir using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The comparison should be using both statistical and graphical approaches to nullify bias.

Methods: An electrospray ionization source with multiple reaction monitoring was used on a Thermo Fisher Scientific Accela HPLC system with a TSQ ENDURA mass spectrometer. DBS extraction method involve use of Whatman 903 paper whereas human plasma method involves protein precipitation. Statistical analyses for method comparison included Bland-Altman and paired t-tests. Box-and-whisker plots and Scatter plots with Deming regression were used in the graphical evaluations.

Results: Both methods were validated according to the ICH M10 guidelines. The graphical and statistical comparison revealed that the DBS approach works within acceptable limits when compared to the human plasma method.

Conclusions: Both methods were effectively examined and compared throughout a linearity range of 50-5000 ng/mL. The validated DBS method for Remdesivir is a strong and dependable alternative to traditional plasma-based sampling. Because of its minimal invasive nature, the DBS technique is ideal for clinical and therapeutic drug monitoring applications.