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目的建立毛细管电泳法测定盐酸头孢吡肟中N-甲基吡咯烷的不确定度评定方法。方法依据《测量不确定度评定与表示》(JJF1059-1999)的规则,建立不确定度计算的数学模型,并推导出不确定度计算公式。结果通过分析试验过程不确定度因素,确定不确定度分量,并合成不确定度,最终计算扩展不确定度,C=(0.0375±0.0066)%,K=2。结论采用该方法建立的数学模型可用于毛细管电泳法测定活性成分中杂质含量的不确定度评定。
OBJECTIVE To establish a method for the determination of the uncertainty of N-methylpyrrolidine hydrochloride in cefepime hydrochloride by capillary electrophoresis. Methods Based on the rules of “Evaluation and Expression of Measurement Uncertainty” (JJF1059-1999), the mathematical model of uncertainty calculation was established and the formula of calculation of uncertainty was deduced. Results By analyzing the uncertainty factors of the test process, the components of uncertainty were determined, and the uncertainty was synthesized. Finally, the extended uncertainty was calculated, C = (0.0375 ± 0.0066)% and K = 2. Conclusion The mathematical model established by this method can be used to evaluate the uncertainty of the impurity content in the active components by capillary electrophoresis.