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首页> 外文期刊>Journal of mass spectrometry: JMS >Evaluating bioanalytical capabilities of paper spray ionization for abiraterone drug quantification in patient plasma
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Evaluating bioanalytical capabilities of paper spray ionization for abiraterone drug quantification in patient plasma

机译：评估纸张喷射电离的生物分析能力，对患者血浆中的Abiraatorone药物量化

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Paper spray ionization (PSI) is a direct, fast, and low-cost ambient ionization technique which may have clinical utility for qualitative and quantitative analysis of therapeutic drugs and metabolites from patient specimens. We developed and validated a PSI-mass spectrometry (PSI-MS/MS) method according to the US-FDA guidelines for bioanalytical studies to measure the prostate cancer drug abiraterone directly from patient plasma. The established linearity range was 3.1-156.8 ng/mL with a precision (%CV) and an accuracy (%) range of 0.5-10.7 and 93.5-103.2, respectively. The mean internal standard normalized matrix factor for abiraterone was just below 1 with highest %CV of 10.2 at the low-level quality control. In benchmarking the performance of this assay against a published LC-MS/MS assay, we showed they were mostly equivalent, with the exception of accuracy with clinical samples. We found the quantitative values observed for abiraterone measured directly from patient plasma using PSI-MS/MS showed positive bias. Upon investigation, we concluded the increased values were due to summed quantitation of isomeric abiraterone conjugates and metabolites which are separable by LC-MS/MS, but not with the current PSI-MS/MS configuration. Despite demonstrating the utility of PSI-MS/MS for rapid bioanalysis, this study also highlighted a limitation encountered with the direct analysis of abiraterone in clinical samples.
机译：纸喷纸电离（PSI）是一种直接，快速，且低成本的环境电离技术，可具有从患者标本的治疗药物和代谢物的定性和定量分析的临床效用。我们根据生物分析研究的US-FDA指南开发并验证了PSI - 质谱（PSI-MS / MS）方法，以直接从患者血浆中测量前列腺癌药物abiraatorone。建立的线性度范围为3.1-156.8ng / ml，精度（％cv）和0.5-10.7和93.5-103.2分别为0.5-10.7和93.5-103.2的精度（％）。 ABIRATERONE的平均内标归一化基质因子仅在1以下，在低水平质量控制下最高％CV为10.2。在基于发表的LC-MS / MS测定的对该测定的性能基准测试中，我们显示它们大多是等效的，除了临床样本的准确性。我们发现使用PSI-MS / MS直接从患者血浆中测量的ABIRATERONE观察到的定量值显示阳性偏压。在调查后，我们得出结论，增加的值是由于异构体缀合物的总和定量和可通过LC-MS / MS可分离的异构体缀合物和代谢物，但不具有当前的PSI-MS / MS构型。尽管证明了PSI-MS / MS进行快速生物分析的效用，但该研究还强调了临床样品中AbiraTerone的直接分析遇到的限制。

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