A Rapid and Simple HPLC-MS/MS Method for the Quantitative Determination of Colistin for Therapeutic Drug Monitoring in Clinical Practice.

IF 4.7 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2024-11-01 eCollection Date: 2024-01-01 DOI:10.2147/DDDT.S479329

Na Zhang, Yiran Xu, Beibei Liang, Jinru Zeng, Rui Wang, Yun Cai

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引用次数: 0

Abstract

Colistin is the last-line option for the treatment of multidrug-resistant gram-negative bacterial infections with narrow therapeutic window. It is essential to ensure its efficacy and safety by therapeutic drug monitoring (TDM). Quantitative determination of colistin is difficult due to its complex ingredients. Previous determination methods demand intricate sample pre-treatment which are not only time-consuming but also costly, and is difficult to apply in clinical practice. Therefore, in order to carry out quantitative determination of colistin accurately and quickly, we establish a rapid high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) with simple sample pre-treatment process. The sample was purified by acetonitrile to remove the plasma protein. Then purified colistin was effectively separated from terfenadine, an internal standard (IS) using Phenomenex Kinetex C18 column (50.0×2.1mm, 5µm) with acetonitrile and water mobile phase at a flow rate of 0.5 mL/min and 40°C column temperature. Colistin and IS were monitored in positive ion mode. Our method expressed good linearity in 50.0~6000 ng/mL of colistin B and 28.31~3397.51 ng/mL of colistin A in plasma. Methodology validations, including selectivity, precision, accuracy, recovery, stability, matrix effect, and dilution integrity met acceptance criteria of Bioanalytical Method Validation (M10) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

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用于临床治疗药物监测的快速简便高效液相色谱-质谱/质谱法定量测定可乐定。

可乐定是治疗耐多药革兰氏阴性菌感染的最后选择，治疗窗口狭窄。通过治疗药物监测（TDM）确保其疗效和安全性至关重要。由于可乐定成分复杂，因此很难对其进行定量测定。以往的测定方法需要对样品进行复杂的预处理，不仅耗时，而且成本高昂，很难应用于临床实践。因此，为了准确、快速地定量检测秋水仙素，我们建立了一种样品前处理过程简单的快速高效液相色谱-串联质谱（HPLC-MS/MS）检测方法。样品经乙腈净化，去除血浆蛋白。然后使用 Phenomenex Kinetex C18 色谱柱（50.0×2.1 毫米，5 微米），以乙腈和水为流动相，流速为 0.5 mL/min，柱温为 40°C，将纯化的可乐定与内标物特非那定有效分离。采用正离子模式监测秋水仙素和 IS。结果表明，该方法在血浆中的线性范围为50.0～6000 ng/mL的秋水仙素B和28.31～3397.51 ng/mL的秋水仙素A。方法的选择性、精密度、准确度、回收率、稳定性、基质效应和稀释完整性均符合国际人用药品技术要求协调理事会（ICH）生物分析方法验证（M10）的验收标准。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.