Establishment and verification of gas chromatography method for determination of 2-phenoxyethanol in Sabin inactivated poliovirus vaccine(Vero cells)
10.13200/j.cnki.cjb.004464
- VernacularTitle:Sabin株脊髓灰质炎灭活疫苗（Vero细胞）中2-苯氧乙醇含量气相色谱检测方法的建立及验证
- Author:
CHENG Bin
- Publication Type:Journal Article
- Keywords:
2-phenoxyethanol;
Sabin inactivated poliovirus vaccine(sIPV);
Gas chromatography(GC)
- From:
Chinese Journal of Biologicals
2025;38(04):457-461
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish and verify a gas chromatography(GC) method for the determination of 2-phenoxyethanol content in Sabin inactivated poliovirus vaccine(sIPV)(Vero cells), thereby providing a reliable approach for detecting 2-phenoxyethanol content in biological products. Methods A polyethylene glycol(PEG) GC column(30 m × 0. 25 mm ×0. 25 μm) was employed for the determination of 2-phenoxyethanol content. The chromatographic conditions were as follows:nitrogen as the carrier gas, an injection volume of 1 μL, a split ratio of 1∶ 10, and a carrier gas flow rate of 1 mL/min.The temperature program was set with an initial column temperature of 90 ℃, followed by a ramp at a rate of 10 ℃ per minute to 220 ℃, which was maintained for 10 minutes. The signal was collected by flame ionization detector(FID). The method was verified for the linear range, repeatability, accuracy, and specificity. The established GC method and high-performance liquid chromatography(HPLC) were used to analyze 2-phenoxyethanol content in three batches of sIPV(Vero cells)respectively, and the results were compared. Results The reference solution exhibited a good linear relationship with the peak area in the concentration range of 0. 2-1. 0 mg/mL, with the linear equation: y = 4 021. 44 x + 97. 07, R2= 0. 998. The relative standard deviation(RSD) of 2-phenoxyethanol content in six test solutions was less than 2. 0%. The spiked recovery rates of high, medium, and low concentrations of 2-phenoxyethanol in nine test samples ranged from 90% to 110%. Both the reference and test solutions showed a distinct chromatographic peak for 2-phenoxyethanol at 9. 1 min, while no such peak was observed in the negative control, indicating no interference with the test samples. The mean 2-phenoxyethanol content in three batches of test samples, as determined by GC and HPLC, was(4. 990 ± 0. 175) and(4. 986 ± 0. 122) mg/mL, respectively, with no statistically significant difference(t = 0. 045 6, P = 0. 967 8). Conclusion The established GC method demonstrates good repeatability, accuracy, and specificity, showing potential as a viable alternative to HPLC for the quantification of 2-phenoxyethanol.
