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Title:: Determination of the Residual Isopropanol in Cross-linked Sodium Hyaluronate by Gas Chromatography

Author(s):: LI Hongmei; ZHANG Suwen; ZHU Xiaojie; GOU Xiuju; MENG Jianwen; WANG Xiaochen; ZHU Xiaomin; Shandong Academy of Pharmaceutical Science,Shandong Provincial Key Laboratory of Biomedical Polymers,Jinan 250101，China

Keywords:: Cross-linked Sodium hyaluronate; Headspace gas chromatography; Residual isopropanol; Crosslinkingl; Determination

摘要:: 建立了气相色谱法测定交联透明质酸钠凝胶中异丙醇残留量的方法。选用DB-624毛细管柱（30 mm×0.535 mm，3.0 μm），氢火焰离子化检测器（FID)，载气为氮气，流速为2.0 ml/min，柱温采用程序升温，初始温度为50℃，保持2 min，以10℃/min升温至160℃，后运行温度：50℃，保持1 min。异丙醇在浓度0.01083~0.8664 mg/ml的范围内，峰面积和浓度呈现良好的线性关系，相关系数0.9990；平均回收率为99.1%，相对标准偏差（RSD）为1.2%。该方法重现性好、灵敏度高、简单、准确。

Abstract:: A method for determination of resiual isopropanol in cross-linked sodium hyaluronate by GC chromatography was established.The method was programmed with Agilent DB-624 capillary column(30 mm×0.535mm,3.0 μm)and FID detector.The carrier was nitrogen and the flow rate was 2.0 ml/min,the oven introduced sequential increasing of temperature programming.The initial column temperature was 50℃ and maintained it for 2 min，then raised it to 160℃ at a rate of 10℃/min,after running temperature to 50℃，maintained it for 1 min.The calibration showed a good calibration linearity with the range of 0.01083~0.8664 mg/ml for isopropanol and the correlation coefficient was 0.9990.The average recoveries were in the range of 99.1%.The relative standard deviations(RSD) was 1.2% .The method has good repeatability and high sensitivity and the method is simple and accurate.