Safety Monitoring

Determination of residual sodium octanoate in human immunoglobulin(10%)by gas chromatography*

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  • 1. Shanxi Kangbao Biological Product Co., Ltd., Changzhi 046000, China;
    2. School of Pharmaceutical Sciences Jilin University,Changchun 130012, China

Received date: 2022-11-29

  Online published: 2024-06-24

Abstract

Objective: To establish a capillary gas chromatography method for the determination of sodium octanoate residues in intravenous human immunoglobulin (10%). Methods: ZB-FFAP capillary column (15 m×0.53 mm×1.0 μm) was adopted, the column temperature was 160 ℃, the gasification chamber temperature was 230 ℃. Nitrogen was used as the carrying gas. Hydrogen flame detector (FID) was used and the detector temperature was 230 ℃. The flow rate was 8 mL·min-1, the split ratio was 23∶1 and the sample volume was 1 μL. Heptanoic acid were used as the internal standard. Results: No sodium octanoate residue was detected in three batches of samples. The resolution between octanoic acid peak and heptanoic acid peak were higher than 1.5. The trailing factor of octanoic acid peak was between 0.95 and 1.20. Octanoic acid standard solution was injected for 5 times, RSD of the ratio between the peak area of octanoic acid and heptanoic acid was less than 5%. Blank matrix had no effect on the peak of octanoic acid and heptanoic acid. Linearity of octanoic acid in the range of 100-300 μg was good and correlation coefficient(r) was greater than 0.99. The limits of detection and quantification were 0.010 mg·mL-1 and 0.033 mg·mL-1, respectively. The average recovery of three different concentrations of samples was 100.1%. The retention time of main peak and internal standard peak was only affected by increasing and decreasing the temperature respectively, and the experimental results were stable. Conclusion: The method established in this study was simple, sensitivity and environmentally friendly. The results were accurate and reproducible. The method can be used for the determination of sodium octanoate residue in intravenous human immunoglobulin (10%).

Cite this article

HE Li-juan, CHEN Tong-wei, SHEN Yun-fei, LU Hai-bin . Determination of residual sodium octanoate in human immunoglobulin(10%)by gas chromatography*[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(9) : 1507 -1513 . DOI: 10.16155/j.0254-1793.2023.09.08

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