顶空气相色谱法测定医用透明质酸钠凝胶中乙醇残留量的不确定度

Uncertainty of Determination of Ethanol in Medical Sodium Hyaluronate Gel by Headspace Gas Chromatography

按YY 0308-2004要求,采用顶空气相色谱法测定了医用透明质酸钠凝胶中的乙醇残留量,依据JJF l059-1999,CNAS-GL 06,对测量结果的不确定度来源进行了系统分析,并对各不确定度分量进行了评定和量化,计算了合成标准不确定度和扩展不确定度,测定结果为(344.10±37.51)μg/g,k=2。结果表明,影响测量结果的主要因素为标准曲线拟合引入的不确定度。

According to YY 0308-2004, ethanol in medical sodium hyaluronate gel was determined by headspace gas chromatography. According to JJF 1059-1999 and CNAS-GL 06, the uncertainty of the measurement results were analyzed systematically. Uncertainty component was evaluated and quantified. The result of the measurement of ethanol in medical sodium hyaluronate gel was expressed as： （344.10 ±37.51） μg/g, k=2. The result showed that the main factor affected determination result was the uncertainty introducd by standard curve.