Quantitation of paracetamol by liquid chromatography-mass spectrometry in human plasma in support of clinical trial

利用液相色谱-质谱法定量分析人血浆中的对乙酰氨基酚,以支持临床试验

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Abstract

AIM: Paracetamol is a well-tolerated antipyretic widely used in severe malaria management. The study aimed to develop and validate a rapid LC-MS/MS assay to quantify paracetamol in plasma from patients with severe malaria. MATERIALS & METHODS: Plasma sample was precipitated by organic solvent containing isotope-labeled paracetamol internal standard. Supernatant was isolated, diluted with water, followed by LC-MS/MS analysis. RESULTS: Plasma samples were extracted and assayed in less than 5.5 min. The assay response was linear (0.125-50 mg/l) with total intra- and interassay imprecision of <1.4%, which were considerably lower than most published reports. CONCLUSION: We developed, validated and applied a rapid and small volume LC-MS/MS assay with high precision and accuracy for plasma paracetamol quantitation in 989 samples from 62 patients with severe malaria. The simple and high-throughput quality could facilitate assay automation for future clinical studies.

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