Objective: To explore a general method for determination of ethylene oxide residue in pharmaceutical packaging materials. Methods: Gas chromatography(GC) with DB-VRX capillary column was used to determine ethylene oxide residue. The headspace balance condition was 60 ℃ for 40 min, the column temperature was constantly on 50 ℃, and the carrier gas flow rate was 1.5 mL·min-1. Results: The established GC analysis method could effectively separate acetaldehyde in drug packaging materials with good specificity. The linearity of ethylene oxide was good at the range of 0.38-18.96 μg·mL-1 (r=0.999 8). The recoveries at low, medium and high additive levels were 96.8%-109.9% with RSDs between 0.9% and 5.1%. Through the verification of extraction time and temperature, the common headspace condition for the packaging materials, such as eye drops and prefilled syringes were discussed. The results showed that the residual amounts of ethylene oxide in the bottle, inside cap of low density polyethylene eye drops and glass prefilled syringe assembly were 3.80, 14.41 and 99.65 μg·g-1, respectively. Conclusion: By evaluating the extraction conditions of different kinds of pharmaceutical packaging materials, a scientific and reasonable sample preparation method was obtained, and a specific and good analysis method was established, which could scientifically evaluate the residual amount of ethylene oxide residue in pharmaceutical packaging materials.
LIU Ai-juan, MENG Kai, CHEN Lei, SHEN Yong, LIU Xue-ting, WANG Chen-xiao, XU Zhi-zhou
. Ethylene oxide residue determination in medicinal packaging materials by gas chromatography*[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(7)
: 1216
-1222
.
DOI: 10.16155/j.0254-1793.2022.07.15
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