Analytical Research Development, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Electrophoresis. 2022 Jul;43(13-14):1408-1414. doi: 10.1002/elps.202100189. Epub 2022 Apr 26.
Polysorbate-80 (PS80) and histidine are common excipients in vaccine and therapeutic protein formulation. A simple quantitative NMR method to measure both PS80 and histidine in human papillomavirus (HPV) virus-like particle (VLP) vaccine for aqueous and alum-containing samples is described. The new NMR method is compared to current colorimetric methods for PS80 and RP HPLC for histidine. The new NMR method is comparable to current assays with an advantage of a simpler sample treatment for PS80. The efficiency is also increased because one method can now provide two assay results instead of two separate methods. Furthermore, the NMR method can detect PS80 stability due to hydrolysis and oxidation when PS80 is stored in a stainless steel container by observing a change of its NMR line shape profile.
聚山梨酯 80（PS80）和组氨酸是疫苗和治疗性蛋白制剂中的常见赋形剂。本文描述了一种简单的定量 NMR 方法，用于测量水性和含铝样品中人乳头瘤病毒（HPV）病毒样颗粒（VLP）疫苗中的 PS80 和组氨酸。新的 NMR 方法与当前用于 PS80 的比色法和用于组氨酸的反相高效液相色谱法（RP HPLC）进行了比较。与当前的检测方法相比，新的 NMR 方法具有更简单的 PS80 样品处理优势。由于一种方法现在可以提供两个检测结果，而不是两种单独的方法，因此效率也得到了提高。此外，当 PS80 存放在不锈钢容器中时，NMR 方法可以通过观察其 NMR 谱线形状轮廓的变化来检测由于水解和氧化导致的 PS80 稳定性。
