Seserko Lauren A, Emory Joshua F, Hendrix Craig W, Marzinke Mark A
Division of Clinical Pharmacology, Department of Medicine, The Johns Hopkins University School of Medicine, 600 North Wolfe St, Osler 501, Baltimore, MD 21287, USA.
Bioanalysis. 2013 Nov;5(22):2771-83. doi: 10.4155/bio.13.256.
Dapivirine is a non-nucleoside reverse transcriptase inhibitor designed to prevent HIV-1 viral replication and subsequent propagation. A sensitive method is required to quantify plasma concentrations to assess drug efficacy.
Dapivirine-spiked plasma was combined with acetonitrile containing deuterated IS and was processed for analysis. The method has an analytical measuring range from 20 to 10,000 pg/ml. For the LLOQ, low, mid and high QCs, intra- and inter-assay precision (%CV) ranged from 5.58 to 13.89% and 5.23 to 13.36%, respectively, and intra- and inter-day accuracy (% deviation) ranged from -5.61 to 0.75% and -4.30 to 6.24%, respectively.
A robust and sensitive LC-MS/MS assay for the high-throughput quantification of the antiretroviral drug dapivirine in human plasma was developed and validated following bioanalytical validation guidelines. The assay meets criteria for the analysis of samples from large research trials.
达匹韦林是一种非核苷类逆转录酶抑制剂，旨在防止HIV-1病毒复制及后续传播。需要一种灵敏的方法来定量血浆浓度以评估药物疗效。
将添加了达匹韦林的血浆与含有氘代内标的乙腈混合，并进行分析处理。该方法的分析测量范围为20至10,000 pg/ml。对于最低定量限、低、中、高质控样品，批内和批间精密度（%CV）分别为5.58%至13.89%和5.23%至13.36%，批内和日间准确度（%偏差）分别为-5.61%至0.75%和-4.30%至6.24%。
按照生物分析验证指南，开发并验证了一种用于高通量定量人血浆中抗逆转录病毒药物达匹韦林的稳健且灵敏的液相色谱-串联质谱法。该方法符合大型研究试验样品分析的标准。
