Clavijo Claudia, Bendrick-Peart Jamie, Zhang Yan Ling, Johnson Gillian, Gasparic Antje, Christians Uwe
Clinical Research & Development, Department of Anesthesiology, University of Colorado Health Sciences Center, Aurora, CO, United States.
J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Oct 15;874(1-2):33-41. doi: 10.1016/j.jchromb.2008.08.021. Epub 2008 Sep 5.
To support animal studies and clinical pharmacokinetic trials, we developed and validated an automated, specific and highly sensitive LC-MS/MS method for the quantification of naltrexone and 6beta-naltrexol in the same run. In human plasma, the assay had a lower limit of quantitation of only 5pg/mL. This was of critical importance to follow naltrexone pharmacokinetics during its terminal elimination phase. The assay had the following key performance characteristics for naltrexone in human plasma: range of reliable quantification: 0.005-100ng/mL (r2>0.99), inter-day accuracy (0.03ng/mL): 103.7% and inter-day precision: 10.1%. There were no ion suppression, matrix interferences or carry-over.
为支持动物研究和临床药代动力学试验，我们开发并验证了一种自动化、特异性强且灵敏度高的液相色谱-串联质谱法，可在同一次运行中对纳曲酮和6β-纳曲醇进行定量分析。在人血浆中，该检测方法的定量下限仅为5 pg/mL。这对于在纳曲酮终末消除阶段跟踪其药代动力学至关重要。该检测方法在人血浆中对纳曲酮具有以下关键性能特征：可靠定量范围：0.005 - 100 ng/mL（r2>0.99），日间准确度（0.03 ng/mL）：103.7%，日间精密度：10.1%。不存在离子抑制、基质干扰或残留。
