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Bioanalytical method validation and sample analysis for nirmatrelvir in dried blood collected using the Tasso-M20 device. | LitMetric

AI Article Synopsis

  • * Nirmatrelvir was extracted from about 20 μl of dried blood using methanol and analyzed through high-performance liquid chromatography with tandem mass spectrometry.
  • * The method was fully validated, showing that hematocrit levels do not affect accuracy, and it performed well in various clinical studies, demonstrating strong stability under different storage conditions.

Article Abstract

A sensitive and selective method for the determination of nirmatrelvir in dried human blood collected by Tasso-M20 was developed and validated from 20.0 to 20,000 ng/ml. Nirmatrelvir and its stable-labeled internal standard were isolated from approximately 20 μl of blood dried on one volumetric absorptive pad inside the Tasso-M20 device by extraction with methanol, followed by dilution of the supernatant. The extracts were analyzed by high-performance liquid chromatography coupled with tandem mass spectrometric detection. The method was fully validated. Hematocrit levels do not impact assay accuracy. Stabilities to cover sample drying and storage at a variety of conditions were conducted. The validated method was used in multiple clinical studies with excellent performance.

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Source
http://dx.doi.org/10.4155/bio-2022-0167DOI Listing

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