Metabolic and Newborn Screening Laboratory, Department of Paediatrics, University of Szeged.
Metabolic and Newborn Screening Laboratory, Department of Paediatrics, University of Szeged.
J Chromatogr B Analyt Technol Biomed Life Sci. 2021 Aug 1;1179:122846. doi: 10.1016/j.jchromb.2021.122846. Epub 2021 Jun 25.
Simultaneous determination of kynurenines, neurotransmitters, pterins and steroids linked to various neurological and metabolic diseases have important diagnostic significance for related pathology and drug monitoring. An improved, sensitive and selective ultra-high performance liquid chromatography coupled to electrospray ionization triple quadrupole mass spectrometric (UHPLC-MS/MS) method, based on our earlier publication, has been proposed for the quantitative measurement of 42 metabolites in human urine. The assay covers a larger number of analytes, uses an advanced, Waters Atlantis T3 chromatographic column and similarly meets the guideline of European Medicines Agency (EMA) on bioanalytical method validation. Analytical performance met all the EMA requirements and the assay covered the relevant clinical concentrations. Linear correlation coefficients were all > 0.998. Intra-day and inter-day accuracy and precision were 87-118%, 81-120% and 2-20%, respectively including the lower limit of quantification (LLOQ). The assay is expected to facilitate the diagnosis and allows drug level monitoring from urine.
同时测定与各种神经和代谢疾病相关的犬尿氨酸、神经递质、蝶呤和类固醇，对相关病理和药物监测具有重要的诊断意义。本研究基于我们之前的研究成果，提出了一种改进的、灵敏且选择性的超高效液相色谱-电喷雾串联三重四极杆质谱（UHPLC-MS/MS）方法，用于定量测定人尿液中的 42 种代谢物。该方法涵盖了更多的分析物，采用了先进的 Waters Atlantis T3 色谱柱，同样符合欧洲药品管理局（EMA）关于生物分析方法验证的指南。分析性能符合所有 EMA 要求，且检测涵盖了相关的临床浓度范围。线性相关系数均大于 0.998。日内和日间精密度和准确度分别为 87%-118%、81%-120%和 2%-20%，包括定量下限（LLOQ）。该方法有望促进诊断，并允许从尿液中监测药物水平。
