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目的建立气相色谱内标法(GC)测定甘氨双唑钠中乙醇残留量的测量不确定度评定方法。方法通过建立气相色谱内标法测定含量的数学模型,对各个不确定度因素进行评估,计算合成不确定度,最终给出测量结果在95%置信区间下的扩展不确定度。结果本次实验的甘氨双唑钠中的乙醇残留量测定结果为(0.46±0.01)%。结论建立的不确定度评定法适用于气相内标法测定药物有机溶剂残留量的不确定度分析。
Objective To establish a method for the determination of the uncertainty of the determination of ethanol residues in glycidrazole sodium by gas chromatography (GC). Methods The gas chromatographic internal standard method was used to determine the content of the model. The uncertainties were evaluated and the combined uncertainty was calculated. Finally, the extended uncertainty of the measurement under the 95% confidence interval was given. Results The result of this experiment was (0.46 ± 0.01)%. Conclusion The uncertainty assessment method established is suitable for the determination of the uncertainty of the residual organic solvents by gas phase internal standard method.