ADVANCEMENT OF DRIED BLOOD SPOT TECHNIQUE WITH REMDESIVIR BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION IN HUMAN BLOOD AS PER ICH M10 GUIDELINE

SUBHRANSHU PANDA; TUSHAR CHAVAN; RAVINDRA BHAVSAR

doi:10.22159/ajpcr.2025v18i7.54759

Authors

SUBHRANSHU PANDA Department of Analytical, School of Pharmaceutical Sciences, Jaipur National University, Jaipur, Rajasthan, India.
TUSHAR CHAVAN Department of Analytical, School of Pharmaceutical Sciences, Jaipur National University, Jaipur, Rajasthan, India. https://orcid.org/0009-0008-7137-2879
RAVINDRA BHAVSAR Department of Clinical, Pharmadesk Solutions Private Limited, Navi Mumbai, Maharashtra, India.

DOI:

https://doi.org/10.22159/ajpcr.2025v18i7.54759

Keywords:

Remdesivir, Dried Blood Spot, Bioanalytical Method Validation, Bioanalysis, Clinical study, ICHM10, LC-MS/MS

Abstract

Objective: The objective of the study was to develop and validate a simple, accurate, and sensitive DBS assisted liquid chromatography–mass spectrometry LC–MS/MS method for the determination of Remdesivir in human blood using Remdesivir D5 as internal standard as per ICH M10 guideline.

Methods: For quantification, an electrospray ionization source with multiple reaction monitoring was employed on a Thermo Fisher Scientific Accela HPLC coupled with a TSQ ENDURA mass spectrometer. Waters Symmetry C18 column, used in combination with a highly organic acidified mobile phase, provided a prominent and consistent response with a run time of 3 minutes. The DBS technique was further refined using Whatman 903 DBS card to extract Remdesivir in acidified methanol.

Results: Method validation was conducted in accordance with ICH M10 guidelines. This method demonstrated excellent performance, with within-run and between-run precision below 7% and QC sample accuracy ranging from 95-109%.

Conclusion: Validated calibration range of 50–5000 ng/mL is well-suited for human clinical or therapeutic drug monitoring studies, particularly given Cmax of approximately 2229 ng/mL observed in human.

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