Bioanalytical method validation and sample analysis for nirmatrelvir in dried blood collected using the Tasso-M20 device
Autor: | Katty X, Wan, Daniel, Potts, Pilar, Gonzalez, Ian, Smith, Haihong, Shi, Olga, Kavetska |
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Rok vydání: | 2022 |
Předmět: | |
Zdroj: | Bioanalysis. 14:1305-1315 |
ISSN: | 1757-6199 1757-6180 |
DOI: | 10.4155/bio-2022-0167 |
Popis: | Aim: 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. Materials & methods: 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. Results & conclusion: 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. |
Databáze: | OpenAIRE |
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