Li Wenkui, Doherty John, Fu Yunlin, Flarakos Jimmy
Department of Pharmacokinetic Sciences, Novartis Institutes for BioMedical Research, East Hanover, New Jersey, USA.
Biomed Chromatogr. 2018 Feb;32(2). doi: 10.1002/bmc.4068. Epub 2017 Sep 20.
An LC-MS/MS method was developed and validated for bioanalysis of clofazimine in human dried blood spot (DBS) samples in support of a clinical study on multidrug-resistant tuberculosis in developing countries. The validated assay dynamic range was from 10.0 to 2000 ng/mL using a 1/8 inch DBS punch. The accuracy and precision of the assay were ±11.0% (bias) and ≤13.5% (CV) for the LLOQs (10.0 ng/mL) and ±15% (bias) and ≤15% (CV) for all other QC levels. The assay was proved to be free from the possible impact owing to spot size and storage temperature (e.g. at 60°C, ≤ - 60°C). The validated assay is well suited for the intended clinical study where conventional pharmacokinetic sample collection is not feasible.
开发并验证了一种液相色谱-串联质谱（LC-MS/MS）方法，用于分析人类干血斑（DBS）样本中的氯法齐明，以支持一项针对发展中国家耐多药结核病的临床研究。使用1/8英寸的DBS冲孔，验证后的分析方法动态范围为10.0至2000 ng/mL。该分析方法的准确度和精密度在LLOQ（10.0 ng/mL）时为±11.0%（偏差）和≤13.5%（CV），在所有其他质量控制水平下为±15%（偏差）和≤15%（CV）。该分析方法被证明不受斑点大小和储存温度（如60°C、≤ - 60°C）的可能影响。经过验证的分析方法非常适合于传统药代动力学样本采集不可行的预期临床研究。
