Saponins from Quillaja saponaria have been commonly used as immunomodulatory adjuvants in foot‐and‐mouth disease vaccines (FMDVs). However, due to the lack of consensus over the possible exacerbation of local inflammatory responses in cattle and its economic impacts, their use has been discouraged by Brazilian authorities. A qualitative method intended to determine the presence of saponins from Q. saponaria bark extracts in FMDVs was developed and validated. Instrumental analysis was performed using an liquid chromatography (LC) coupled to a quadrupole–time‐of‐flight–mass spectrometry (TOF‐MS) system. The method was validated according to the International Conference on Harmonization Harmonized Tripartite Guideline Q2 (R1) and Brazilian Ministry of Agriculture, Livestock and Food Supply Analytical Quality Assurance Guidelines. Validation parameters were determined and considered suitable to the established criteria. The validated method has been applied in routine analysis in the National Agricultural Laboratory at Rio Grande do Sul (LANAGRO‐RS). All results obtained were in agreement with the vaccine's composition described by the manufacturer. The method is easy and adequate for analysis in routine laboratories. To the best of the authors' knowledge, this is the first report of a method which intends to investigate the presence of saponins from Q. saponaria bark extracts in veterinary vaccines.

中文翻译：

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液相色谱-四极杆飞行时间质谱（LC-QTOF-MS）方法鉴定口蹄疫疫苗中Quillaja saponaria树皮提取物的皂苷的鉴定分析：开发，验证和适用性。

Quillaja saponaria的皂苷通常被用作口蹄疫疫苗（FMDV）的免疫调节佐剂。但是，由于对牛局部炎症反应可能加重及其经济影响缺乏共识，巴西当局不鼓励使用它们。一种定性方法，旨在确定皂角Q.皂苷的存在FMDV中的树皮提取物已开发并验证。使用液相色谱（LC）结合四极杆飞行时间质谱（TOF-MS）系统进行仪器分析。该方法已根据国际协调三方协调会议Q2（R1）和巴西农业，畜牧业和粮食供应分析质量保证指南进行了验证。确定验证参数，并认为它们适合于已建立的标准。经验证的方法已在南里奥格兰德州国家农业实验室（LANAGRO-RS）的常规分析中应用。获得的所有结果均与制造商描述的疫苗组成一致。该方法简便易行，适合常规实验室进行分析。尽最大的努力兽医疫苗中的皂角树皮提取物。