Reversed-phase LC assay method for deoxycholate in influenza vaccine

Area of Science:

• Analytical Chemistry
• Biopharmaceutical Analysis
• Vaccine Manufacturing Quality Control

Background:

• Sodium deoxycholate (DCA) is utilized in influenza vaccine production for particle disruption.
• Current methods for residual DCA detection in vaccines are labor-intensive and lack specificity.
• Accurate quantification of residual DCA is critical for vaccine safety and efficacy.

Purpose of the Study:

• To develop and validate a more specific and efficient assay for residual deoxycholic acid in vaccine preparations.
• To establish a reliable analytical method for quality control of influenza vaccines.

Main Methods:

• Development of a reversed-phase liquid chromatography (LC) method for deoxycholic acid quantification.
• Utilized solid-phase extraction (SPE) for sample clean-up and concentration of deoxycholic acid.
• Employed cholic acid as an internal standard for accurate ratio-based calculations.

Main Results:

• The LC method demonstrated quantitative recovery during the SPE clean-up procedure.
• Achieved a linearity range of 3–200 µg/mL with a low limit of detection (0.4 µg on column).
• Quantified residual DCA in influenza vaccine lots between 10–16 µg/mL, showing higher specificity than spectrophotometry.

Conclusions:

• The developed reversed-phase LC method provides a highly specific and reliable assay for residual deoxycholic acid in vaccine preparations.
• This LC method offers a significant improvement over traditional colorimetric assays for vaccine quality control.
• The findings support the adoption of this LC method for routine analysis of residual DCA in influenza vaccines.