Key result
Validated LC-QTOF-MS method successfully identifies saponins in foot-and-mouth disease vaccines.
Why the study?
The use of saponins from Quillaja saponaria bark extracts in foot-and-mouth disease vaccines has been discouraged due to concerns about exacerbating local inflammatory responses and economic impacts, necessitating a validated method to identify their presence.
A novel LC-QTOF-MS method was successfully developed and validated to detect Quillaja saponaria saponins in foot-and-mouth disease vaccines, facilitating routine quality control.
May support FMD vaccine quality control; leaves open multi-lab standardization and broader biologics use.
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.
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Andrade et al. (2020) studied Foot-and-mouth disease vaccines. LC-QTOF-MS analytical method was evaluated on Method validation parameters according to ICH and Brazilian Ministry of Agriculture guidelines. An LC-QTOF-MS method was successfully developed and validated for the qualitative identification of saponins from Quillaja saponaria bark extracts in foot-and-mouth disease vaccines.
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