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Title:: Determination of Residual P-dioxanone in Biodegradable Poly(P-dioxanone)

Author(s):: ZHU Aichen; MA Lixia; YANG Qinghua; LIU Yang; WANG Chuandong; LI Junqi; Shandong Academy of Pharmaceutical Sciences, Shandong Provincial Key Laboratory of Biomedical Polymers, Jinan 250101, China

Keywords:: Poly(P-dioxanone); P-dioxanone; Residual monomer; Gas chromatography (GC); Biodegradation

摘要:: 建立聚二氧环己酮原料中单体二氧环己酮残留量的气相色谱测试方法。采用DB-624毛细管色谱柱(30.0 m×535 μm×3.00 μm)，程序升温(146 ℃保持5 min,30 ℃/min升温至200 ℃，保持2 min)。载气为氮气，氢火焰离子化检测器(FID)，进样口温度240 ℃，检测器温度250 ℃，分流比5:1，进样量2 μL。结果显示单体在0.0239~0.1794 mg/mL范围内线性关系良好，平均回收率为100.3 %，RSD为1.39，检测限浓度为0.2 μg/mL，定量限浓度为0.5 μg/mL。该方法简便快捷、准确度和灵敏度高。

Abstract:: A gas chromatography method was established for determination of residual P-dioxanone in poly (P-dioxanone). DB-624 capillary column (30.0 m×535 μm×3.00 μm) was used, the oven temperature was initially held at 146 ℃ for 5 min and then programmed to 200 ℃ at 30 ℃/min and held for another 2 min. The carrier gas was nitrogen, the injection port temperature was 240 ℃, and the temperature of FID was set at 250 ℃. The split ratio was 5:1 and the sample volume was set at 2 μL. The results showed that the concentration of P-dioxanone was good linear in the range of 0.0239~0.1794 mg/mL. The recovery of P-dioxanone was 100.3 %, and the relative standard deviation was 1.39 %. The limit of detection was 0.0002 mg/mL, and the limit of quantification was 0.0005 mg/mL. The method is simple, rapid, accurate and sensitive.