Meng Min, Zhang Jianbo, Liu Aihua, Reuschel Scott, Sazani Pete, Wong Michael
Covance Laboratories, Inc, Salt Lake City, UT 84124, USA.
Sarepta Therapeutics Incorporated.
Bioanalysis. 2017 May;9(10):827-839. doi: 10.4155/bio-2016-0289. Epub 2017 May 18.
AVI-7100 (Radavirsen) is a 20-mer phosphorodiamidate morpholino oligomer (PMOplus®) for the treatment of influenza. Results/methodology: An automated solid-phase extraction method was used to extract plasma samples (200 μl). The extracts were analyzed using liquid chromatography coupled with tandem mass spectrometry under the positive ionization mode. This method was fully validated over the calibration curve range of 5.00-1000 ng/ml. The between-run precision and accuracy ranged from 0.0 to 5.2% relative standard deviation and 91.6 to 100.0% of nominal for all quality control concentrations, including the lower limit of quantitation.
DISCUSSION/CONCLUSION: This is the first liquid chromatography coupled with tandem mass spectrometry method for the measurement of AVI-7100 concentrations in human plasma. It has been used to support regulated bioanalysis.
AVI - 7100（Radavirsen）是一种用于治疗流感的20聚体磷酰二胺吗啉代寡聚物（PMOplus®）。结果/方法：采用自动固相萃取法提取血浆样本（200μl）。提取物在正离子模式下通过液相色谱 - 串联质谱法进行分析。该方法在5.00 - 1000 ng/ml的校准曲线范围内得到充分验证。包括定量下限在内的所有质量控制浓度的批间精密度和准确度的相对标准偏差范围为0.0%至5.2%，标称值的91.6%至100.0%。
讨论/结论：这是首个用于测定人血浆中AVI - 7100浓度的液相色谱 - 串联质谱法。它已被用于支持规范的生物分析。
