Khalid S. Abd-Elaziz , Rex Cheng , Joe Chen , Hans Maarse , Yisheng Lee , Wenjin Yang , Benjamin Chien , Zuzana Diamant , Jos Kosterink , Daniël J. Touw
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This assay was validated in compliance with the Food and Drug Administration (FDA) Good Laboratory Practice Regulations (GLP) and European Medicines Agency (EMA) guidelines.</p><p>K<sub>2</sub>EDTA human plasma samples were spiked with internal standard, processed by liquid–liquid extraction, and analyzed using reversed-phase HPLC with Turbo Ion Spray® MS/MS detection. Separation was done using a chromatographic gradient on 5 µm C6-Phenyl 110 Å, 50*2 mm analytical column at a temperature of 35 °C.</p><p>The LC-MS/MS bioanalytical method, developed by QPS Taiwan to determine the concentration of Aderamastat in K<sub>2</sub>EDTA human plasma, was successfully validated with respect to linearity, sensitivity, accuracy, precision, dilution, selectivity, hemolyzed plasma, lipemic plasma, batch size, recovery, matrix effect, and carry-over. 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This assay was validated in compliance with the Food and Drug Administration (FDA) Good Laboratory Practice Regulations (GLP) and European Medicines Agency (EMA) guidelines.</p><p>K<sub>2</sub>EDTA human plasma samples were spiked with internal standard, processed by liquid–liquid extraction, and analyzed using reversed-phase HPLC with Turbo Ion Spray® MS/MS detection. Separation was done using a chromatographic gradient on 5 µm C6-Phenyl 110 Å, 50*2 mm analytical column at a temperature of 35 °C.</p><p>The LC-MS/MS bioanalytical method, developed by QPS Taiwan to determine the concentration of Aderamastat in K<sub>2</sub>EDTA human plasma, was successfully validated with respect to linearity, sensitivity, accuracy, precision, dilution, selectivity, hemolyzed plasma, lipemic plasma, batch size, recovery, matrix effect, and carry-over. These data indicate that the method for determination of Aderamastat concentrations in human K<sub>2</sub>EDTA plasma can be used in pharmacokinetics studies and subsequent clinical trials with Aderamastat.</p><p>Authors declare that, this novel data is not published and not under consideration for publication by another journal than this journal. 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引用次数: 0
摘要
阿德拉马司他（FP-025）是一种小分子、选择性基质金属蛋白酶（MMP）-12抑制剂，正在开发用于治疗呼吸系统疾病，其中可能包括慢性炎症性气道疾病和肺纤维化。为了支持阿德拉马司他人体药代动力学参数的评估，我们开发并验证了一种高效液相色谱串联质谱（LC-MS/MS）分析方法，用于定量检测人体血浆中的阿德拉马司他。K2EDTA 人体血浆样品中添加了内标物，经液液萃取处理，采用反相高效液相色谱法和 Turbo Ion Spray® MS/MS 检测器进行分析。该方法在线性、灵敏度、准确度、精密度、稀释度、选择性、溶血血浆、脂血血浆、批量、回收率、基质效应和携带等方面均得到了验证。这些数据表明，测定人体 K2EDTA 血浆中阿德拉马司他浓度的方法可用于阿德拉马司他的药代动力学研究和后续临床试验。所有数据将应要求提供。
Validation of a method for the determination of Aderamastat (FP-025) in K2EDTA human plasma by LC-MS/MS
Aderamastat (FP-025) is a small molecule, selective matrix metalloproteinase (MMP)-12 inhibitor, under development for respiratory conditions which may include chronic inflammatory airway diseases and pulmonary fibrosis.
To support evaluation of the pharmacokinetic parameters of Aderamastat in humans, we developed and validated a high-performance liquid chromatography tandem mass spectrometry (LC-MS/MS) analytical method for the quantification of Aderamastat in human plasma. This assay was validated in compliance with the Food and Drug Administration (FDA) Good Laboratory Practice Regulations (GLP) and European Medicines Agency (EMA) guidelines.
K2EDTA human plasma samples were spiked with internal standard, processed by liquid–liquid extraction, and analyzed using reversed-phase HPLC with Turbo Ion Spray® MS/MS detection. Separation was done using a chromatographic gradient on 5 µm C6-Phenyl 110 Å, 50*2 mm analytical column at a temperature of 35 °C.
The LC-MS/MS bioanalytical method, developed by QPS Taiwan to determine the concentration of Aderamastat in K2EDTA human plasma, was successfully validated with respect to linearity, sensitivity, accuracy, precision, dilution, selectivity, hemolyzed plasma, lipemic plasma, batch size, recovery, matrix effect, and carry-over. These data indicate that the method for determination of Aderamastat concentrations in human K2EDTA plasma can be used in pharmacokinetics studies and subsequent clinical trials with Aderamastat.
Authors declare that, this novel data is not published and not under consideration for publication by another journal than this journal. All data will be made available on request.
期刊介绍：
The Journal of Chromatography B publishes papers on developments in separation science relevant to biology and biomedical research including both fundamental advances and applications. Analytical techniques which may be considered include the various facets of chromatography, electrophoresis and related methods, affinity and immunoaffinity-based methodologies, hyphenated and other multi-dimensional techniques, and microanalytical approaches. The journal also considers articles reporting developments in sample preparation, detection techniques including mass spectrometry, and data handling and analysis.
Developments related to preparative separations for the isolation and purification of components of biological systems may be published, including chromatographic and electrophoretic methods, affinity separations, field flow fractionation and other preparative approaches.
Applications to the analysis of biological systems and samples will be considered when the analytical science contains a significant element of novelty, e.g. a new approach to the separation of a compound, novel combination of analytical techniques, or significantly improved analytical performance.
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